Drugs

FDA

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

  • Kelly Wilson
  • March 19, 2025
  • Drugs
  • No Comments

On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1).

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FDA

FDA Issues FY24 Drug Safety Priorities Report

  • Kelly Wilson
  • February 26, 2025
  • Drugs
  • No Comments

CDER’s latest Drug Safety Priorities Fiscal Year 2024 report highlights the extensive work of its multidisciplinary teams, showcasing significant safety-related milestones and achievements. These efforts underscore CDER’s ongoing commitment to promote and protect public health by addressing potential medication risks and enhancing safety measures. The report highlights continuing initiatives to combat the overdose crisis, including…

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FDA

FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma

  • Kelly Wilson
  • February 12, 2025
  • Drugs
  • No Comments

On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade…

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FDA

FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection

  • Kelly Wilson
  • February 11, 2025
  • Drugs
  • No Comments

On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.

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FDA

FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS | FDA

  • Kelly Wilson
  • February 7, 2025
  • Drugs
  • No Comments

On January 21, 2025, the Food and Drug Administration approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

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FDA

FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer

  • Kelly Wilson
  • January 17, 2025
  • Drugs
  • No Comments

On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy…

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FDA

FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection

  • Kelly Wilson
  • December 27, 2024
  • Drugs
  • No Comments

On December 27, 2024, the Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb Company) indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

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FDA

FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

  • Kelly Wilson
  • December 20, 2024
  • Drugs
  • No Comments

On December 20, 2024, the Food and Drug Administration granted accelerated approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.

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FDA

FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients

  • Kelly Wilson
  • December 19, 2024
  • Drugs
  • No Comments

On December 18, 2024, the Food and Drug Administration approved remestemcel-L-rknd (Ryoncil, Mesoblast, Inc.), an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients 2 months of age and older. Ryoncil is the first FDA-approved MSC therapy.

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FDA

FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma

  • Kelly Wilson
  • December 16, 2024
  • Drugs
  • No Comments

On December 13, 2024, the Food and Drug Administration approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.

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FDA

FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma

  • Kelly Wilson
  • December 4, 2024
  • Drugs
  • No Comments

On December 4, 2024, the Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with the following: advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring…

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FDA

FDA approves updated drug labeling for fludarabine phosphate under Project Renewal

  • Kelly Wilson
  • November 20, 2024
  • Drugs
  • No Comments

On November 19, 2024, the Food and Drug Administration approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) 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 third…

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FDA

FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma

  • Kelly Wilson
  • October 18, 2024
  • Drugs
  • No Comments

On October 18, 2024, the Food and Drug Administration approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are…

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FDA

FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma

  • Kelly Wilson
  • October 18, 2024
  • Drugs
  • No Comments

On October 18, 2024, the Food and Drug Administration approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are…

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FDA

FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

  • Kelly Wilson
  • October 11, 2024
  • Drugs
  • No Comments

On October 10, 2024, the Food and Drug Administration approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

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FDA

FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer

  • Kelly Wilson
  • October 7, 2024
  • Drugs
  • No Comments

On October 3, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR)…

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FDA

FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy | FDA

  • Kelly Wilson
  • September 25, 2024
  • Drugs
  • No Comments

On September 25, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations,…

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FDA

FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations | FDA

  • Kelly Wilson
  • September 19, 2024
  • Drugs
  • No Comments

On September 19, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment…

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FDA

FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer

  • Kelly Wilson
  • September 18, 2024
  • Drugs
  • No Comments

On September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and…

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FDA

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

  • Kelly Wilson
  • September 12, 2024
  • Drugs
  • No Comments

On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS)….

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FDA

FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer

  • Kelly Wilson
  • August 20, 2024
  • Drugs
  • No Comments

On August 19, 2024, the Food and Drug Administration approved lazertinib (Lazcluze, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by…

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FDA

FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer

  • Kelly Wilson
  • August 16, 2024
  • Drugs
  • No Comments

On August 15, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic…

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FDA

FDA approves axatilimab-csfr for chronic graft-versus-host disease

  • Kelly Wilson
  • August 15, 2024
  • Drugs
  • No Comments

On August 14, 2024, the Food and Drug Administration approved axatilimab-csfr (Niktimvo, Incyte Corporation), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

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FDA

FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation

  • Kelly Wilson
  • August 6, 2024
  • Drugs
  • No Comments

On August 6, 2024, the Food and Drug Administration approved vorasidenib (Voranigo, Servier Pharmaceuticals LLC), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total…

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FDA

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

  • Kelly Wilson
  • August 2, 2024
  • Drugs
  • No Comments

On August 2, 2024, the Food and Drug Administration granted accelerated approval to afamitresgene autoleucel (TECELRA, Adaptimmune, LLC), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4…

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FDA

FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy

  • Kelly Wilson
  • August 1, 2024
  • Drugs
  • No Comments

On August 1, 2024, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer (EC). Dostarlimab-gxly previously was approved with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent EC that is mismatch repair deficient…

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FDA

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma

  • Kelly Wilson
  • July 31, 2024
  • Drugs
  • No Comments

On July 30, 2024, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research & Development, LLC) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

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FDA

FDA finalizes guidance on RWD from electronic health records

  • Kelly Wilson
  • July 25, 2024
  • Drugs
  • No Comments

The US Food and Drug Administration (FDA) has finalized its guidance on evaluating real-world data (RWD) from electronic health records (EHR). The final guidance offers additional clarification on selecting study variables and validation and includes recommendations for the use of quantitative approaches to aid in interpreting study results and analyzing potential misclassifications.

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FDA

FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia

  • Kelly Wilson
  • June 24, 2024
  • Drugs
  • No Comments

On June 14, 2024, the Food and Drug Administration approved blinatumomab (Blincyto, Amgen Inc.) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy.

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FDA

FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer

  • Kelly Wilson
  • June 24, 2024
  • Drugs
  • No Comments

On June 21, 2024, the Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc., a Bristol Myers Squibb company) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

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FDA

FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

  • Kelly Wilson
  • June 13, 2024
  • Drugs
  • No Comments

On June 13, 2024, the Food and Drug Administration granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe…

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FDA

FDA approves selpercatinib for RET fusion-positive thyroid cancer

  • Kelly Wilson
  • June 13, 2024
  • Drugs
  • No Comments

On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

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FDA

FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia

  • Kelly Wilson
  • June 7, 2024
  • Drugs
  • No Comments

On June 6, 2024, the Food and Drug Administration approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible…

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FDA

FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS

  • Kelly Wilson
  • April 23, 2024
  • Drugs
  • No Comments

On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approvalExternal Link Disclaimer for this…

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FDA

FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

  • Kelly Wilson
  • March 23, 2024
  • Drugs
  • No Comments

On March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Patients are selected based on an FDA-approved test. Mirvetuximab soravtansine-gynx previously received…

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FDA

FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications

  • Kelly Wilson
  • March 1, 2024
  • Drugs
  • No Comments

On March 1, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of 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.

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FDA

FDA Issues FY23 Drug Safety Priorities Report

  • Kelly Wilson
  • February 21, 2024
  • Drugs
  • No Comments

Fiscal year 2023 was another challenging but productive year for CDER, with dedicated staff across the Center working tirelessly to carry out our critical mission to promote and protect public health by identifying and managing drug safety issues that arose. Check out the CDER Drug Safety Priorities Fiscal Year 2023 report, which highlights key safety-related…

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FDA

FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma

  • Kelly Wilson
  • February 16, 2024
  • Drugs
  • No Comments

On February 16, 2024, the Food and Drug Administration granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.

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FDA

FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma

  • Kelly Wilson
  • February 14, 2024
  • Drugs
  • No Comments

On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. Full prescribing information for Onivyde will be posted here. Efficacy was evaluated in NAPOLI 3 (NCT04083235), a randomized, multicenter, open-label, active-controlled trial in 770 patients with metastatic…

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FDA

Kite Receives U.S. FDA Approval Of Manufacturing Process Change Resulting In Reduced Median Turnaround Time For Yescarta® CAR T-Cell Therapy

  • Kelly Wilson
  • January 30, 2024
  • Drugs
  • No Comments

(Gilead) Jan 30, 2024 – Kite, a Gilead Company, today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel). With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to…

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FDA

Drug Safety Communication

  • Amanda Bridges
  • January 19, 2024
  • Drugs
  • No Comments

Based on a completed U.S. Food and Drug Administration (FDA) review of available information, we have concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease (CKD), particularly patients on dialysis. Severe hypocalcemia appears to be more common in patients…

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FDA

FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma

  • Amanda Bridges
  • January 19, 2024
  • Drugs
  • No Comments

On January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is…

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FDA

FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer

  • Amanda Bridges
  • January 12, 2024
  • Drugs
  • No Comments

On January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer. Full prescribing information for Keytruda will be posted here. Efficacy was evaluated in KEYNOTE-A18 (NCT04221945), a multicenter, randomized, double-blind, placebo-controlled trial enrolling 1060 patients with cervical cancer who had not previously…

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FDA

FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer

  • Amanda Bridges
  • December 15, 2023
  • Drugs
  • No Comments

On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy. Full prescribing information for Padcev and Keytruda…

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FDA

FDA approves belzutifan for advanced renal cell carcinoma

  • Amanda Bridges
  • December 15, 2023
  • Drugs
  • No Comments

On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Full prescribing information for Welireg will be posted here. Efficacy…

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FDA

FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma

  • Amanda Bridges
  • December 13, 2023
  • Drugs
  • No Comments

On December 13, 2023, the Food and Drug Administration approved eflornithine (IWILFIN, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. This represents the first FDA approval of a therapy intended…

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FDA

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

  • Amanda Bridges
  • December 4, 2023
  • Drugs
  • No Comments

On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Prescribing information for Jaypirca will be posted here….

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FDA

Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

  • Amanda Bridges
  • December 1, 2023
  • Drugs
  • No Comments

The U.S. Food and Drug Administration (FDA) is informing consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic syringes made in China used…

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FDA

FDA approves nirogacestat for desmoid tumors

  • Amanda Bridges
  • November 27, 2023
  • Drugs
  • No Comments

On November 27, 2023, the Food and Drug Administration approved nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. Full prescribing information for OGSIVEO will be posted here. Efficacy was evaluated in DeFi (NCT03785964), an international, multicenter, randomized (1:1), double-blind,…

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FDA

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

  • Amanda Bridges
  • November 17, 2023
  • Drugs
  • No Comments

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). The full prescribing information for Xtandi will be posted here. Efficacy was evaluated…

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FDA

FDA approves repotrectinib for ROS1-positive non-small cell lung cancer

  • Amanda Bridges
  • November 16, 2023
  • Drugs
  • No Comments

On November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI…

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