FDA Approves Teclistamab in Combination With Daratumumab Hyaluronidase-fihj for Relapsed or Refractory Multiple Myeloma
On March 5, the FDA approved teclistamab in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. For more information, read the FDA announcement and the Johnson & Johnson press release.
FDA Grants Accelerated Approval to Zongertinib for Unresectable or Metastatic Non-squamous Non-small Cell Lung Cancer
On February 26, the FDA granted accelerated approval to zongertinib, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. For more information, read the FDA announcement and visit the Boehringer Ingelheim Pharmaceuticals website.
FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer With a BRAF V600E Mutation
On February 24, the FDA granted traditional approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test. For more information, read the FDA announcement and the Pfizer press release.
FDA Approves Acalabrutinib With Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
On February 19, the FDA approved acalabrutinib tablets and capsules in combination with venetoclax for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. For more information, read the FDA announcement and the AstraZeneca press release.
FDA Approves Novocure’s Optune Pax for the Treatment of Locally Advanced Pancreatic Cancer
On February 11, the FDA approved Optune Pax® for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. For more information, read the Novocure press release.
FDA Approves Pembrolizumab With Paclitaxel for Platinum-resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
On February 10, the FDA approved pembrolizumab as well as pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens. For more information, read the FDA announcement and the Merck press release.
Safety Labeling Update for Capecitabine and Fluorouracil on Risks Associated With Dihydropyrimidine Dehydrogenase Deficiency
The FDA is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All health care providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary. For more information, read the FDA announcement.
FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma
On December 21, the FDA approved CD20xCD3 bispecific mosunetuzumab-axgb as a subcutaneous formulation for the treatment of adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. For more information, read the Genentech press release.
FDA Approves Daratumumab and Hyaluronidase-fihj With Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma
On January 27, the FDA approved daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. For more information, read the FDA announcement and the Johnson & Johnson press release.
Sun Pharma Announces the Availability of Cosibelimab-ipdl for Advanced Cutaneous Squamous Cell Carcinoma
On January 16, 2026, Sun Pharmaceutical Industries announced that UNLOXCYT™ (cosibelimab-ipdl) is now available in the US for health care professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. For more information, read the Sun Pharmaceutical Industries press release.
FDA Approves Amivantamab and Hyaluronidase-lpuj for Subcutaneous Injection
On December 17, the FDA approved amivantamab and hyaluronidase-lpuj for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab. For more information, read the FDA announcement and the Janssen Biotech press release.
FDA Grants Regular Approval to Rucaparib for Metastatic Castration-resistant Prostate Cancer
On December 17, the FDA approved rucaparib for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy. For more information, read the FDA announcement and visit the pharmaand website.
FDA Approves Fam-trastuzumab Deruxtecan-nxki With Pertuzumab for Unresectable or Metastatic HER2-positive Breast Cancer
On December 15, the FDA approved fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test. For more information, read the FDA announcement and the AstraZeneca press release.
FDA Approves Niraparib and Abiraterone Acetate Plus Prednisone for BRCA2-mutated Metastatic Castration-sensitive Prostate Cancer
On December 12, the FDA approved niraparib and abiraterone acetate with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test. For more information, read the FDA announcement and visit the Janssen Biotech website.
FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Marginal Zone Lymphoma
On December 4, the FDA approved lisocabtagene maraleucel for adults with relapsed or refractory marginal zone lymphoma who have received at least 2 prior lines of systemic therapy. For more information, read the FDA announcement and the Bristol Myers Squibb press release.
FDA Grants Traditional Approval to Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
On December 3, the FDA granted traditional approval to pirtobrutinib for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor. For more information, read the FDA announcement and the Lilly press release.
FDA Approves Durvalumab for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
On November 25, the FDA approved durvalumab with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma. For more information, read the FDA announcement and the AstraZeneca press release.
FDA Approves Pembrolizumab With Enfortumab Vedotin-ejfv for Muscle Invasive Bladder Cancer
On November 21, the FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin. For more information, read the FDA announcement and the Merck press release.
FDA Grants Traditional Approval to Tarlatamab-dlle for Extensive Stage Small Cell Lung Cancer
On November 19, the FDA granted traditional approval to tarlatamab-dlle for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. For more information, read the FDA announcement and the Amgen press release.
FDA Grants Accelerated Approval to Sevabertinib for Non-squamous Non-small Cell Lung Cancer
On November 19, the FDA granted accelerated approval to sevabertinib, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. For more information, read the FDA announcement and the Bayer press release.
FDA Grants Traditional Approval to Daratumumab and Hyaluronidase-fihj for Newly Diagnosed Light Chain Amyloidosis
On November 19, the FDA granted traditional approval to daratumumab and hyaluronidase-fihj with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis. For more information, read the FDA announcement and visit the Janssen Biotech website.
FDA Approves Epcoritamab-bysp for Follicular Lymphoma Indications
On November 18, the FDA approved epcoritamab-bysp with lenalidomide and rituximab for relapsed or refractory follicular lymphoma. The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after 2 or more lines of systemic therapy. For more information, read the FDA announcement and the Genmab press release.
FDA Approves New Interchangeable Biosimilar to Perjeta
On November 13, the FDA approved pertuzumab-dpzb as an interchangeable biosimilar to pertuzumab. For more information, read the FDA announcement and visit the Shanghai Henlius Biologics website.
FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukemia With a NPM1 Mutation
On November 13, the FDA approved ziftomenib, a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options. For more information, read the FDA announcement and the Kura Oncology press release.
