Drugs

FDA

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…

FLASCO

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…

Amgen

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

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…

Novartis Oncology

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…

Genentech

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…

Merck

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

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…

FLASCO

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…

Kite

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…

Incyte

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…

FLASCO

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,…

Seagen

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)….

Takeda

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…

Beigene

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…

Bristol Myers Squibb

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…

GlaxoSmithKline

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…

Merck

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…

Merck

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…

Merck

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…

FLASCO

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…

FLASCO

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…

Janssen | Johnson & Johnson

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…

Astellas

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

  • Amanda Bridges
  • July 9, 2021
  • Drugs
  • No Comments

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

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
  • No Comments

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…

Jazz Pharmaceuticals

FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer

  • Amanda Bridges
  • July 1, 2021
  • Drugs
  • No Comments

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…

Jazz Pharmaceuticals

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

  • Amanda Bridges
  • July 1, 2021
  • Drugs
  • No Comments

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…

Blueprint Medicines

FDA approves avapritinib for advanced systemic mastocytosis

  • Amanda Bridges
  • June 16, 2021
  • Drugs
  • No Comments

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

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

  • Amanda Bridges
  • May 28, 2021
  • Drugs
  • No Comments

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®…

Amgen

FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC

  • Amanda Bridges
  • May 28, 2021
  • Drugs
  • No Comments

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

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

  • Amanda Bridges
  • May 21, 2021
  • Drugs
  • No Comments

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…

Bristol Myers Squibb

FDA approves nivolumab for resected esophageal or GEJ cancer

  • Amanda Bridges
  • May 20, 2021
  • Drugs
  • No Comments

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…

Merck

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

  • Amanda Bridges
  • May 6, 2021
  • Drugs
  • No Comments

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…

GlaxoSmithKline

FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

  • Amanda Bridges
  • April 29, 2021
  • Drugs
  • No Comments

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…

GlaxoSmithKline

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

  • Amanda Bridges
  • April 26, 2021
  • Drugs
  • No Comments

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

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

  • Amanda Bridges
  • April 26, 2021
  • Drugs
  • No Comments

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…

Bristol Myers Squibb

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

  • Amanda Bridges
  • April 16, 2021
  • Drugs
  • No Comments

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…

Immunomedics

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

  • Amanda Bridges
  • April 13, 2021
  • Drugs
  • No Comments

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

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

  • Amanda Bridges
  • April 7, 2021
  • Drugs
  • No Comments

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

FDA approves new dosing regimen for cetuximab

  • Amanda Bridges
  • April 7, 2021
  • Drugs
  • No Comments

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

FDA approves isatuximab-irfc for multiple myeloma

  • Amanda Bridges
  • April 1, 2021
  • Drugs
  • No Comments

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

FDA approves pembrolizumab for esophageal or GEJ carcinoma

  • Amanda Bridges
  • March 23, 2021
  • Drugs
  • No Comments

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

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

  • Amanda Bridges
  • March 11, 2021
  • Drugs
  • No Comments

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

Kite

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

  • Amanda Bridges
  • March 8, 2021
  • Drugs
  • No Comments

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…

Janssen | Johnson & Johnson

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

  • Amanda Bridges
  • March 4, 2021
  • Drugs
  • No Comments

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…

Oncopeptides

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

  • Amanda Bridges
  • March 4, 2021
  • Drugs
  • No Comments

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…

Pfizer

FDA Expands Approval of Lorlatinib for Frontline ALK-Positive NSCLC

  • Amanda Bridges
  • March 4, 2021
  • Drugs
  • No Comments

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%…

FDA

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma

  • Amanda Bridges
  • March 1, 2021
  • Drugs
  • No Comments

Food and Drug Administration granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal…

Sanofi Genzyme

FDA approves Regeneron, Sanofi’s Libtayo for first-line advanced NSCLC with high PD-L1 expression

  • Amanda Bridges
  • February 25, 2021
  • Drugs
  • No Comments

(Sanofi) Feb 22, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Read more >

FDA

FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression

  • Amanda Bridges
  • February 22, 2021
  • Drugs
  • No Comments

On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by…

Sanofi Genzyme

FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma

  • Amanda Bridges
  • February 11, 2021
  • Drugs
  • No Comments

PARIS and TARRYTOWN, N.Y. – February 9, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with an hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted…

FDA

COVID-19 Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 – Drug Information Update

  • Amanda Bridges
  • February 11, 2021
  • Drugs
  • No Comments

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk…

FDA

FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma

  • Amanda Bridges
  • February 10, 2021
  • Drugs
  • No Comments

On February 9, 2021, the Food and Drug Administration granted regular approval to cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC (mBCC)…

FDA

FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma

  • Amanda Bridges
  • February 9, 2021
  • Drugs
  • No Comments

On February 5, 2021, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell…

Bristol Myers Squibb

FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma

  • Amanda Bridges
  • February 9, 2021
  • Drugs
  • No Comments

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the…

EMD Serono

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

  • Amanda Bridges
  • February 4, 2021
  • Drugs
  • No Comments

On February 3, 2021, the Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Efficacy was demonstrated in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced…

Bristol Myers Squibb

FDA Approves Nivolumab Plus Cabozantinib For Advanced Renal Cell Carcinoma

  • Amanda Bridges
  • January 28, 2021
  • Drugs
  • No Comments

(FDA.gov) Jan 22, 2021 – On January 22, 2021, the Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma (RCC). Efficacy was evaluated in CHECKMATE-9ER (NCT03141177), a randomized, open-label trial in patients with previously untreated advanced RCC….

FDA

FDA Updates Vinca Alkaloid Labeling for Preparation in Intravenous Infusion Bags Only

  • Amanda Bridges
  • January 20, 2021
  • Drugs
  • No Comments

[1/15/21] The U.S. Food and Drug Administration is alerting health care professionals to labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate (for) injection, and vinorelbine tartrate injection. To reduce the potential for unintended intrathecal (spinal) administration, which causes death or severe neurological injury, FDA…

Daiichi-Sankyo

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

  • Amanda Bridges
  • January 20, 2021
  • Drugs
  • No Comments

On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Efficacy was evaluated in a multicenter, open-label, randomized trial (DESTINY-Gastric01, NCT03329690) in patients with HER2-positive locally advanced or metastatic…

Pfizer

FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma

  • Amanda Bridges
  • January 20, 2021
  • Drugs
  • No Comments

On January 14, 2021, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or…

Targeted Oncology

FDA Approves Margetuximab Plus Chemotherapy in HER2+ Metastatic Breast Cancer

  • Amanda Bridges
  • December 17, 2020
  • Drugs
  • No Comments

The FDA granted approval to the Fc-engineered, monoclonal antibody margetuximab (MGAH22) in combination with chemotherapy, as treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, according to a press release from MacroGenics, Inc.1 “Early detection and treatment…

Blueprint Medicines

FDA approves pralsetinib for RET-altered thyroid cancers

  • Amanda Bridges
  • December 8, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

FDA

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

  • Amanda Bridges
  • November 30, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

Merck

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

  • Amanda Bridges
  • November 17, 2020
  • Drugs
  • No Comments

Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. November 13, 2020.  More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-pembrolizumab-locally-recurrent-unresectable-or-metastatic-triple

Foundation Medicine

FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers

  • Amanda Bridges
  • November 9, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

ASCO

FDA Approves FoundationOne CDx As Companion Diagnostic For Larotrectinib To Identify NTRK1/2/3 Gene Fusions Across Solid Tumors

  • Amanda Bridges
  • November 5, 2020
  • Drugs
  • No Comments

OncLive (10/23) reported, “The FDA has approved the FoundationOne CDx (F1CDx)comprehensive genomic test as a companion diagnostic for larotrectinib (Vitrakvi) to identify patients with NTRK1/2/3 gene fusions across all solid tumors.” The test “is currently the sole FDA-approved tissue-based comprehensive genomic profiling assay that is indicated to detect NTRK1/2/3 fusions across all solid malignancies and identify…

FDA

FDA Approves VEKLURY (Remdesivir)

  • Kelly Wilson
  • October 25, 2020
  • Drugs
  • No Comments

On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved VEKLURY (remdesivir) for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. VEKLURY should only be administered intravenously (IV) in a hospital or in a healthcare…

Genentech

FDA Grants Full Approval For Venclexta In AML

  • Kelly Wilson
  • October 22, 2020
  • Drugs
  • No Comments

On Friday, the FDA granted full approval for Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this…

Bristol Myers Squibb

FDA Approves Opdivo + Yervoy for Previously Untreated Unresectable Malignant Pleural Mesothelioma

  • Amanda Bridges
  • October 8, 2020
  • Drugs
  • No Comments

Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2 Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1 Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall PRINCETON,…

Blueprint Medicines

FDA Approves GAVRETO (Pralsetinib) For Adult Patients with Metastatic Rearranged During Transfection Fusion-Positive Non-Small Cell Lung Cancer

  • Amanda Bridges
  • October 2, 2020
  • Drugs
  • No Comments

On September 4, 2020, the U.S. Food and Drug Administration (FDA) approved GAVRETO (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Select patients for treatment with GAVRETO based on the presence of a RET gene fusion. Information on…

Celgene

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

  • Amanda Bridges
  • September 4, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

Celgene

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

  • Amanda Bridges
  • September 3, 2020
  • Drugs
  • No Comments

On September 1, 2020, the Food and Drug Administration approved azacitidine tablets (ONUREG®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. More information.

Bristol Myers Squibb

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

  • Amanda Bridges
  • September 3, 2020
  • Drugs
  • No Comments

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

Janssen | Johnson & Johnson

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma

  • Amanda Bridges
  • August 27, 2020
  • Drugs
  • No Comments

On August 20, 2020, the Food and Drug Administration approved carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc.) and daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The efficacy of carfilzomib and daratumumab with dexamethasone was evaluated in two…

Guardant Health

FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

  • Amanda Bridges
  • August 13, 2020
  • Drugs
  • No Comments

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine…

GlaxoSmithKline

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

  • Amanda Bridges
  • August 6, 2020
  • Drugs
  • No Comments

On August 5, 2020, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Belantamab mafodotin-blmf was evaluated in DREAMM-2 (NCT 03525678), an open-label, multicenter trial….

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

  • Amanda Bridges
  • August 4, 2020
  • Drugs
  • No Comments

On July 31, 2020, the Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for…

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