The FDA on January 27, 2026, approved DARZALEX FASPRO® in combination with Bortezomib, Lenalidomide, and Dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for Autologous Stem Cell Transplant (ASCT). DARZALEX FASPRO® is a product of Janssen Biotech, Inc.
Category: FDA Approvals
RYBREVANT FASPRO® (Amivantamab and Hyaluronidase-lpuj)
The FDA on December 17, 2025, approved RYBREVANT FASPRO® for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of RYBREVANT®. See the prescribing information for the specific indications. RYBREVANT FASPRO® is a product of Janssen Biotech, Inc.
AKEEGA® (Niraparib and Abiraterone acetate)
The FDA on December 12, 2025, approved AKEEGA® 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. AKEEGA® is a product of Janssen Biotech, Inc.
RUBRACA® (Rucaparib)
The FDA on December 17, 2025, approved RUBRACA® 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). RUBRACA® is a product of pharmaand GmbH.
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
The FDA on December 15, 2025, approved ENHERTU® 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. ENHERTU® is a product of Daiichi Sankyo, Inc.
BREYANZI® (Lisocabtagene maraleucel)
The FDA on December 4, 2025, approved BREYANZI® for adults with relapsed or refractory Marginal Zone Lymphoma (MZL) who have received at least two prior lines of systemic therapy. BREYANZI® is a product of Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.
JAYPIRCA® (Pirtobrutinib)
The FDA on December 3, 2025, granted traditional approval to JAYPIRCA® 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 JAYPIRCA® for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. JAYPIRCA® is a product of Eli Lilly and Company.
IMFINZI® (Durvalumab)
The FDA on November 25, 2025, approved IMFINZI® with Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI®, for adults with resectable Gastric or GastroEsophageal Junction adenocarcinoma (GC/GEJC). IMFINZI® is a product of AstraZeneca.
KEYTRUDA® or KEYTRUDA QLEX® with PADCEV®
The FDA on November 21, 2025, approved KEYTRUDA® (Pembrolizumab) or KEYTRUDA QLEX® (Pembrolizumab and Berahyaluronidase alfa-pmph) with PADCEV® (Enfortumab vedotin-ejfv) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with Muscle Invasive Bladder Cancer (MIBC) who are ineligible for Cisplatin. KEYTRUDA® and KEYTRUDA QLEX® are products of Merck and PADCEV® is a product of Astellas Pharma.
IMDELLTRA® (Tarlatamab-dlle)
The FDA on November 19, 2025, granted traditional approval to IMDELLTRA® for adults with Extensive Stage Small Cell Lung Cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA® received accelerated approval for this indication in 2024. IMDELLTRA® is a product of Amgen Inc.