FLASCO / Drugs

FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma

Amanda Bridges
August 10, 2023
Drugs
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On August 9, 2023, the Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. View full prescribing information for Talvey. Efficacy was…

FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions

Amanda Bridges
August 9, 2023
Drugs
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On August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Pralsetinib was previously granted accelerated approval for the NSCLC indication on Sept. 4, 2020, based on initial…

FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer

Amanda Bridges
August 3, 2023
Drugs
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On August 2, 2023, the Food and Drug Administration approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in September 2015….

FDA approves quizartinib for newly diagnosed acute myeloid leukemia

Kelly Wilson
July 21, 2023
Drugs
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On July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an…

FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer

Amanda Bridges
June 21, 2023
Drugs
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On June 20, 2023, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). View full prescribing information for Talzenna Efficacy was evaluated in TALAPRO-2 (NCT03395197), a randomized, double-blind, placebo-controlled, multi-cohort trial enrolling 399 patients with HRR gene-mutated mCRPC. Patients were randomized…

FDA expands early breast cancer indication for abemaciclib with endocrine therapy

Amanda Bridges
March 6, 2023
Drugs
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On March 3, 2023, the Food and Drug Administration (FDA) approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. Patients defined as…

FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer

Amanda Bridges
February 6, 2023
Drugs
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On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic…

FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma

Amanda Bridges
December 23, 2022
Drugs
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On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Mosunetuzumab-axgb was evaluated in GO29781 (NCT02500407), an open-label, multicenter, multi-cohort study. The efficacy…

FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer

Amanda Bridges
December 19, 2022
Drugs
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On December 16, 2022, the Food and Drug Administration approved nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) for adult patients with high-risk Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Efficacy was evaluated in Study CS-003 (NCT02773849), a multicenter, single-arm trial enrolling 157 patients with high-risk…

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal

Amanda Bridges
December 15, 2022
Drugs
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On December 14, 2022, the Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the first drug to…

FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC

Amanda Bridges
December 13, 2022
Drugs
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On December 12, 2022, the Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C¬-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. FDA…

FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

Amanda Bridges
December 1, 2022
Drugs
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On December 1, 2022, the Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Today, the FDA also approved the Abbott RealTime IDH1 Assay to select patients for olutasidenib. Approval was based on Study 2102-HEM-101…

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

Amanda Bridges
November 22, 2022
Drugs
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The U.S. Food and Drug Administration (FDA) is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Our review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or…

FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)

Amanda Bridges
November 18, 2022
Drugs
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On November 18, 2022, the Food and Drug Administration approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours…

FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer

Amanda Bridges
November 16, 2022
Drugs
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On November 14, 2022, the Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc.) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a folate receptor alpha directed antibody…

FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

Amanda Bridges
November 10, 2022
Drugs
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On November 10, 2022, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen, Inc.) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for brentuximab vedotin. Efficacy was evaluated in…

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer

Amanda Bridges
September 22, 2022
Drugs
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On September 21, 2022, the Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. Today, FDA also approved the Oncomine Dx Target (ODxT)…

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

Amanda Bridges
September 22, 2022
Drugs
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On September 21, 2022, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Efficacy…

FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement

Amanda Bridges
August 30, 2022
Drugs
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On August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement. Efficacy was evaluated in FIGHT-203 (NCT03011372), a multicenter open-label, single-arm trial that included 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement. Eligible…

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

Amanda Bridges
August 12, 2022
Drugs
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On August 11, 2022, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a…

FDA approves capmatinib for metastatic non-small cell lung cancer

Amanda Bridges
August 11, 2022
Drugs
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On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test. Capmatinib was previously granted accelerated approval for the…

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer

Amanda Bridges
August 7, 2022
Drugs
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On August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Efficacy was based on ARASENS (NCT02799602), a randomized, multicenter, double-blind, placebo-controlled clinical trial in 1306 patients with mHSPC. Patients were randomized to receive either darolutamide…

FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor

Amanda Bridges
July 14, 2022
Drugs
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On July 14, 2022, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). The safety and efficacy of crizotinib were evaluated in two multicenter, single-arm, open-label trials that included 14…

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

Amanda Bridges
June 30, 2022
Drugs
No Comments

What safety concern is FDA announcing? The U.S. Food and Drug Administration (FDA) is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. The trial…

FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma

Amanda Bridges
June 27, 2022
Drugs
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On June 24, 2022, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for…

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

Amanda Bridges
June 23, 2022
Drugs
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On June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory…

FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications

Amanda Bridges
June 1, 2022
Drugs
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On May 27, 2022, the Food and Drug Administration approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC): nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-based chemotherapy nivolumab in combination with ipilimumab (Yervoy, Bristol-Myers Squibb Company) Efficacy was evaluated in CHECKMATE-648 (NCT03143153), a…

FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma

Amanda Bridges
June 1, 2022
Drugs
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On May 27, 2022, the Food and Drug Administration granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval was based on the ELARA trial (NCT03568461), a multicenter, single-arm, open-label trial evaluating tisagenlecleucel, a CD19-directed chimeric…

FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns

Amanda Bridges
June 1, 2022
Drugs
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6-1-2022 FDA Drug Safety Communication Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL). Updated findings from the UNITY-CLL clinical trial continued to show a…

FDA approves alpelisib for PIK3CA-related overgrowth spectrum

Amanda Bridges
April 6, 2022
Drugs
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On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Efficacy was evaluated using real-world data from EPIK-P1 (NCT04285723), a single-arm clinical study in patients…

FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma

Amanda Bridges
April 1, 2022
Drugs
No Comments

On April 1, 2022, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma. Approval was…

FDA approves Pluvicto for metastatic castration-resistant prostate cancer

Amanda Bridges
March 24, 2022
Drugs
No Comments

On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. On the…

FDA approves Opdualag for unresectable or metastatic melanoma

Amanda Bridges
March 21, 2022
Drugs
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On March 18, 2022, the Food and Drug Administration approved nivolumab and relatlimab-rmbw (Opdualag, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab. Efficacy was evaluated in…

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)

Amanda Bridges
February 3, 2022
Drugs
No Comments

2-3-2022 FDA Drug Safety Communication The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system. We determined that initial findings from a clinical trial evaluating Ukoniq to…

FDA approves rituximab plus chemotherapy for pediatric cancer indications

Amanda Bridges
December 3, 2021
Drugs
No Comments

On December 2, 2021, the Food and Drug Administration approved rituximab (Rituxan, Genentech, Inc.) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). Efficacy was evaluated in Inter-B-NHL Ritux 2010 (NCT01516580), a global multicenter, open-label, randomized (1:1) trial of…

FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma

Amanda Bridges
December 1, 2021
Drugs
No Comments

On November 30, 2021, the Food and Drug Administration approved daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Efficacy was evaluated in a single-arm cohort of PLEIADES (NCT03412565), a…

FDA approves sirolimus protein-bound particles for malignant perivascular epithelioid cell tumor

Amanda Bridges
November 23, 2021
Drugs
No Comments

On November 22, 2021, the Food and Drug Administration approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Efficacy was evaluated in AMPECT (NCT02494570), a multicenter, single-arm clinical trial in 31 patients with locally advanced unresectable or…

FDA approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemia

Amanda Bridges
October 29, 2021
Drugs
No Comments

On October 29, 2021, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), and approved asciminib for adult patients with Ph+ CML in CP with the T315I…

FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer

Amanda Bridges
October 15, 2021
Drugs
No Comments

On October 15, 2021, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. Today, the FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device…

FDA approves pembrolizumab combination for the first-line treatment of cervical cancer

Amanda Bridges
October 13, 2021
Drugs
No Comments

On October 13, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. FDA also granted regular approval to pembrolizumab as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors…

FDA approves abemaciclib with endocrine therapy for early breast cancer

Amanda Bridges
October 13, 2021
Drugs
No Comments

On October 12, 2021, the Food and Drug Administration approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment…

FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker information

Amanda Bridges
October 8, 2021
Drugs
No Comments

On October 7, 2021, the Food and Drug Administration granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. FDA recognized a portion of the OncoKB as a source of valid scientific evidence for Level 2 (clinical significance) and Level 3 (potential clinical significance) biomarkers. Under the FDA’s database…

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Amanda Bridges
October 4, 2021
Drugs
No Comments

On October 1, 2021, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Efficacy was evaluated in ZUMA-3 (NCT02614066), a single-arm multicenter trial that evaluated brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, in adults with relapsed…

FDA approves ruxolitinib for chronic graft-versus-host disease

Amanda Bridges
September 23, 2021
Drugs
No Comments

On September 22, 2021, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Efficacy was evaluated in REACH-3 (NCT03112603), a randomized, open-label, multicenter clinical trial of ruxolitinib compared to best…

FDA approves cabozantinib for differentiated thyroid cancer

Amanda Bridges
September 22, 2021
Drugs
No Comments

On September 17, 2021, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine. Efficacy was evaluated in COSMIC-311,…

FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

Amanda Bridges
September 21, 2021
Drugs
No Comments

On September 20, 2021, the Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based on innovaTV 204, an open-label, multicenter, single-arm clinical trial (NCT03438396)….

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Amanda Bridges
September 16, 2021
Drugs
No Comments

On September 15, 2021, the Food and Drug Administration granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based…

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

Amanda Bridges
September 2, 2021
Drugs
No Comments

On August 31, 2021, the Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with Waldenström’s macroglobulinemia (WM). Zanubrutinib was investigated in ASPEN (NCT03053440), a randomized, active control, open-label trial, comparing zanubrutinib and ibrutinib in patients with MYD88 L265P mutation (MYD88MUT) WM. Patients in Cohort 1 (n=201) were randomized 1:1 to receive zanubrutinib…

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

Amanda Bridges
August 27, 2021
Drugs
No Comments

On August 25, 2021, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Today, the FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic…

FDA approves nivolumab for adjuvant treatment of urothelial carcinoma

Amanda Bridges
August 20, 2021
Drugs
No Comments

On August 19, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk UC. The results supporting this approval…

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

Amanda Bridges
August 18, 2021
Drugs
No Comments

On August 17, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. Today, the FDA…

FDA approves belzutifan for cancers associated with von Hippel-Lindau disease

Amanda Bridges
August 13, 2021
Drugs
No Comments

On August 13, 2021, the Food and Drug Administration approved belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Belzutifan was investigated in the ongoing Study…

FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer

Amanda Bridges
July 27, 2021
Drugs
No Comments

On July 26, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. FDA also granted regular approval to pembrolizumab in combination with chemotherapy for patients with locally recurrent…

FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma

Amanda Bridges
July 23, 2021
Drugs
No Comments

On July 21, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or…

FDA approves belumosudil for chronic graft-versus-host disease

Amanda Bridges
July 16, 2021
Drugs
No Comments

On July 16, 2021, the Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. Efficacy was evaluated in KD025-213 (NCT03640481), a randomized, open-label, multicenter dose-ranging…

FDA Approves Enfortumab Vedotin For Locally Advanced/Metastatic Urothelial Carcinoma

Amanda Bridges
July 12, 2021
Drugs
No Comments

Enfortumab vedotin-ejfv has been approved by the FDA for locally advanced or metastatic urothelial cancer. The FDA has approved enfortumab vedotin-ejfv (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously undergone treatment with a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy or who are otherwise ineligible for…

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

Amanda Bridges
July 12, 2021
Drugs
No Comments

On July 9, 2021, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Efficacy was evaluated in APOLLO (NCT03180736), an open-label, active-controlled…

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer

Amanda Bridges
July 9, 2021
Drugs
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On July 9, 2021, the Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or are ineligible for…

Jazz Pharmaceuticals Announces U.S. FDA Approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Amanda Bridges
July 1, 2021
Drugs
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Approval under U.S. FDA’s Real-Time Oncology Review program represents an important therapeutic advance for pediatric and adult patients who develop hypersensitivity to E. coli-derived asparaginase treatmentsRylaze is expected to become commercially available in the U.S. in mid-JulyCompany to host investor webcast in July; details to follow DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced…

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

Amanda Bridges
July 1, 2021
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Today, the U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. The only other FDA-approved drug for such patients…

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma

Amanda Bridges
July 1, 2021
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On June 30, 2021, the Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. Efficacy…

FDA approves avapritinib for advanced systemic mastocytosis

Amanda Bridges
June 16, 2021
Drugs
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On June 16, 2021, the Food and Drug Administration approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Efficacy was evaluated in EXPLORER (NCT02561988) and PATHFINDER (NCT03580655), two multi-center, single-arm,…

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

Amanda Bridges
May 28, 2021
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On May 28, 2021, the Food and Drug Administration granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. The FDA also approved FoundationOne®…

FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC

Amanda Bridges
May 28, 2021
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On May 28, 2021, the Food and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C ‑mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA ‑approved test, who have received at least one prior systemic therapy. FDA also…

FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

Amanda Bridges
May 21, 2021
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On May 21, 2021, the Food and Drug Administration granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), a bispecific antibody directed against epidermal growth factor (EGF) and MET receptors, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected…

FDA approves nivolumab for resected esophageal or GEJ cancer

Amanda Bridges
May 20, 2021
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On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Efficacy was evaluated in CHECKMATE-577 (NCT02743494), a randomized, multicenter, double-blind trial in 794 patients with completely resected (negative margins) esophageal…

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

Amanda Bridges
May 6, 2021
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On May 5, 2021, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Approval was based on the prespecified interim analysis of…

FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

Amanda Bridges
April 29, 2021
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Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA…

FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer

Amanda Bridges
April 26, 2021
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On April 22, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen. Efficacy was evaluated based on cohort (A1) in GARNET…

FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma

Amanda Bridges
April 26, 2021
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On April 23, 2021, the Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising…

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma

Amanda Bridges
April 16, 2021
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On April 16, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Efficacy was evaluated in CHECKMATE-649 (NCT02872116), a randomized, multicenter, open-label trial that enrolled 1,581 patients with previously untreated advanced or metastatic…

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

Amanda Bridges
April 13, 2021
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On April 13, 2021, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Efficacy and safety were evaluated in TROPHY…

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

Amanda Bridges
April 7, 2021
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On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. In April 2020, sacituzumab govitecan received accelerated approval…

FDA approves new dosing regimen for cetuximab

Amanda Bridges
April 7, 2021
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On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). This approval provides for a biweekly…

FDA approves isatuximab-irfc for multiple myeloma

Amanda Bridges
April 1, 2021
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On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. The efficacy and safety of isatuximab-irfc in combination with carfilzomib and dexamethasone…

FDA approves pembrolizumab for esophageal or GEJ carcinoma

Amanda Bridges
March 23, 2021
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On March 22, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or…

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

Amanda Bridges
March 11, 2021
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Food and Drug Administration approved tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. . March 10, 2021. More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tivozanib-relapsed-or-refractory-advanced-renal-cell-carcinoma

FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma

Amanda Bridges
March 8, 2021
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On March 5, 2021, the Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Approval in FL was based on a single-arm, open-label, multicenter trial (ZUMA-5; NCT03105336) that evaluated axicabtagene ciloleucel, a…

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Amanda Bridges
March 4, 2021
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Action Advances Fight Against COVID-19, Follows Comprehensive Evaluation of Available Safety, Effectiveness and Manufacturing Quality Information by FDA Career Scientists, Input from External Experts Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome…

Now Approved: PEPAXTO® (melphalan flufenamide); Oncopeptides, Inc.

Amanda Bridges
March 4, 2021
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WALTHAM — March 1, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen, in combination with dexamethasone, for the treatment of adult patients with relapsed or…

FDA Expands Approval of Lorlatinib for Frontline ALK-Positive NSCLC

Amanda Bridges
March 4, 2021
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The FDA has approved a supplemental new drug application for lorlatinib (Lorbrena) to expand the indication to include the frontline treatment of patients with ALK-positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. The regulatory based on the data from the pivotal phase 3 CROWN trial (NCT03052608), where lorlatinib resulted in a 72%…