Drugs

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

• Kelly Wilson
• July 3, 2025
• Drugs
• No Comments

On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) 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…

FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

• Kelly Wilson
• July 2, 2025
• Drugs
• No Comments

On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and…

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer

• Kelly Wilson
• June 25, 2025
• Drugs
• No Comments

On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma

• Kelly Wilson
• June 18, 2025
• Drugs
• No Comments

On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).

FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

• Kelly Wilson
• June 15, 2025
• Drugs
• No Comments

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with…

FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

• Kelly Wilson
• May 16, 2025
• Drugs
• No Comments

On May 15, 2025, the Food and Drug Administration approved retifanlimab-dlwr (Zynyz, Incyte Corporation) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC…

FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression

• Kelly Wilson
• May 15, 2025
• Drugs
• No Comments

On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an…

FDA approves belzutifan for pheochromocytoma or paraganglioma

• Kelly Wilson
• May 14, 2025
• Drugs
• No Comments

On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA approval of an oral therapy for PPGL.

FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

• Kelly Wilson
• May 8, 2025
• Drugs
• No Comments

On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

• Kelly Wilson
• April 24, 2025
• Drugs
• No Comments

On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after…

FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma

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

On April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC)

FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer

• Kelly Wilson
• April 8, 2025
• Drugs
• No Comments

On April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated…

FDA approves durvalumab for muscle invasive bladder cancer

• Kelly Wilson
• March 28, 2025
• Drugs
• No Comments

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).

FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication

• Kelly Wilson
• March 28, 2025
• Drugs
• No Comments

On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET

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

On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET).

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).

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…

FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor

• Kelly Wilson
• February 15, 2025
• Drugs
• No Comments

On February 14, 2025, the Food and Drug Administration approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

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…

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.

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).

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…

FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer

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

On January 16, 2025, the Food and Drug Administration approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma

• Kelly Wilson
• January 16, 2025
• Drugs
• No Comments

On January 16, 2025, the Food and Drug Administration granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).

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.

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.

FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer

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

On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.

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.

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.

FDA approves durvalumab for limited-stage small cell lung cancer

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

On December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

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…

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…

FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation

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

On November 15, 2024, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.

FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

• Kelly Wilson
• November 10, 2024
• Drugs
• No Comments

On November 8, 2024, the Food and Drug Administration approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia

• Kelly Wilson
• October 29, 2024
• Drugs
• No Comments

On October 29, 2024, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

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…

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…

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.

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)…

FDA approves selpercatinib for RET fusion-positive medullary thyroid cancer

• Kelly Wilson
• September 29, 2024
• Drugs
• No Comments

On September 27, 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 medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.

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,…

FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

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

On September 20, 2024, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).

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…

FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma

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

On September 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

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…

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…

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…

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.

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…

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…

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…

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).

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.

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma

• Kelly Wilson
• June 26, 2024
• Drugs
• No Comments

On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, 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.

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.

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.

FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma

• Kelly Wilson
• June 17, 2024
• Drugs
• No Comments

On June 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.

FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer

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

On June 14, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

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…

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).

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…

FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma

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

FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors

• Kelly Wilson
• May 29, 2024
• Drugs
• No Comments

On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with the following:

FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer

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

n May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma

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

On May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer

• Kelly Wilson
• April 29, 2024
• Drugs
• No Comments

On April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication.

FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma

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

On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

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…

FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

• Kelly Wilson
• April 22, 2024
• Drugs
• No Comments

On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer

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

On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

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…

FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products

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

On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE).

FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products

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

On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE).

FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

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

On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma

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

On March 7, 2024, the Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma

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

On March 6, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia

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

On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

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.

FDA approves tepotinib for metastatic non-small cell lung cancer

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

On February 15, 2024, the Food and Drug Administration granted traditional 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.

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…