Oncology FDA Approval– category –
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Oncology Drug Approval News Flash FDA approves teclistamab (Tecvayli) plus daratumumab hyaluronidase-fihj for relapsed/refractory multiple myeloma (and converts Tecvayli monotherapy from accelerated to traditional approval)
On March 5, 2026, the U.S. FDA approved teclistamab (Tecvayli), a BCMA×CD3 bispecific antibody, in combination with daratumumab hyaluronidase-fihj for adults with relapsed or refractory multiple myeloma (RRMM) who have received at least ... -
Oncology Drug Approval News Flash: Zongertinib receives accelerated FDA approval for unresectable or metastatic HER2 TKD–mutated non-squamous non-small cell lung cancer in systemic therapy–naïve adults
FDA approval summary On February 26, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor zongertinib (Hernexeos, Boehringer Ingelheim) for an expanded indication in adult patients with u... -
Oncology Drug Approval News Flash: Encorafenib plus cetuximab and fluorouracil-based chemotherapy receives traditional FDA approval for BRAF V600E–mutated metastatic colorectal cancer
FDA approval summary On February 24, 2026, the U.S. Food and Drug Administration (FDA) granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorourac... -
Oncology Drug Approval News Flash: Optune Pax, a low electric field tumor treating fields device, approved with gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer
FDA approval summary On February 11, 2026, the U.S. Food and Drug Administration (FDA) approved a low electric field generator device, Optune Pax (Novocure), in combination with gemcitabine and nab-paclitaxel for the treatment of adult p... -
Oncology Drug Approval News Flash: Pembrolizumab plus paclitaxel with or without bevacizumab approved for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
FDA approval summary On February 10, 2026, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with... -
Oncology Drug Approval News Flash: Daratumumab and hyaluronidase-fihj plus bortezomib, lenalidomide, and dexamethasone approved for newly diagnosed multiple myeloma in transplant-ineligible adults
FDA approval summary On January 27, 2026, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (V... -
Oncology Drug Approval News Flash: FDA grants regular approval to rucaparib for BRCAm mCRPC and approves subcutaneous amivantamab and hyaluronidase-lpuj
FDA approval summary On December 17, 2025, the U.S. Food and Drug Administration (FDA) granted regular approval to rucaparib (Rubraca, pharmaand GmbH) for adult patients with metastatic castration-resistant prostate cancer (mCRPC) associ... -
Oncology Drug Approval News Flash: Fam-trastuzumab deruxtecan-nxki plus pertuzumab approved as first-line therapy for unresectable or metastatic HER2-positive breast cancer
FDA approval summary On December 15, 2025, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with un... -
Oncology Drug Approval News Flash: Niraparib plus abiraterone acetate and prednisone approved for BRCA2-mutated metastatic castration-sensitive prostate cancer
FDA approval summary On December 12, 2025, the U.S. Food and Drug Administration (FDA) approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adult patients with deleterious or suspected deleteriou... -
Oncology Drug Approval News Flash：FDA approves lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma
On December 4, 2025, the U.S. Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol Myers Squibb company), a CD19-directed CAR T-cell therapy, for adult patients with relapsed or ref... -
Oncology Drug Approval News Flash：FDA grants traditional approval to pirtobrutinib (Jaypirca) for adults with relapsed or refractory CLL/SLL after covalent BTK inhibitor therapy
On December 3, 2025, the U.S. Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic l... -
Oncology Drug Approval News Flash：FDA approves durvalumab (Imfinzi) plus FLOT as perioperative therapy for resectable gastric and GEJ adenocarcinoma
On November 25, 2025, the U.S. Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by sin... -
Oncology Drug Approval News Flash: FDA approves perioperative pembrolizumab plus enfortumab vedotin-ejfvfor cisplatin-ineligible muscle invasive bladder cancer (MIBC)
On November 21, 2025, the U.S. FDA approved pembrolizumab (Keytruda / Keytruda Qlex) in combination with enfortumab vedotin-ejfv (Padcev) as neoadjuvant and adjuvant therapy for adults with muscle invasive bladder cancer (MIBC) who are e... -
Oncology Drug Approval News Flash: FDA Grants Full Approval to Tarlatamab-dlle for ES-SCLC and Accelerated Approval to Sevabertinib for HER2-Mutated NSCLC
On November 19, 2025, the U.S. Food and Drug Administration (FDA) granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen) for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed after platinum... -
Oncology Drug Approval News Flash: FDA Approves Selumetinib (KOSELUGO) for Adults with Neurofibromatosis Type 1 and Symptomatic, Inoperable Plexiform Neurofibromas
On November 19, 2025, the U.S. Food and Drug Administration (FDA) approved selumetinib (KOSELUGO, AstraZeneca) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Previously appro... -
Oncology Drug Approval News Flash: FDA Approves Epcoritamab-bysp (Epkinly) with R² for Relapsed or Refractory Follicular Lymphoma
On November 18, 2025, the U.S. Food and Drug Administration (FDA) approved epcoritamab-bysp (Epkinly, Genmab / AbbVie) in combination with lenalidomide and rituximab (R²) for adults with relapsed or refractory follicular lymphoma (FL). T... -
Oncology Drug Approval News Flash: FDA Approves Poherdy (pertuzumab-dpzb) as the First Interchangeable Biosimilar to Perjeta
On November 13, 2025, the U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics) as the first interchangeable biosimilar to Perjeta (pertuzumab, Genentech). This marks a historic step in ex... -
Oncology Drug Approval News Flash: FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma
On November 6, 2025, the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj, Janssen Biotech, Inc.) for the treatment of adults with high-risk smoldering multiple myeloma (SMM). This mark... -
Oncology Drug Approval News Flash: FDA Re-Approves Blenrep (Belantamab Mafodotin) in Combination Therapy for Multiple Myeloma
In October 2025, the U.S. Food and Drug Administration (FDA) granted re-approval to belantamab mafodotin (Blenrep), GSK’s anti-BCMA antibody–drug conjugate (ADC), for use in combination with bortezomib and dexamethasone in patients with ... -
Oncology Drug Approval News Flash: FDA Approves Lurbinectedin Plus Atezolizumab for Maintenance in Extensive-Stage Small Cell Lung Cancer
On October 2, 2025, the U.S. Food and Drug Administration (FDA) approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq, Genentech) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) fo...
