FLASCO
- FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection December 18, 2025On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.). See the prescribing information for the specific indications.
- FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer December 17, 2025On December 17, 2025, the Food and Drug Administration approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx).
- FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer December 16, 2025On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) 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
- FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer December 13, 2025On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.
- FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma December 5, 2025On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.
- FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma December 3, 2025On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL...
- FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma November 25, 2025On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) 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 (GC/GEJC).
- FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis November 19, 2025On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.
- FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas November 19, 2025On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.
- FDA approves epcoritamab-bysp for follicular lymphoma indications November 18, 2025On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for...