The FDA on April 11, 2025, approved OPDIVO® with YERVOY® for the first-line treatment of adult patients with unresectable or metastatic HepatoCellular Carcinoma (HCC). OPDIVO® and YERVOY® are products of Bristol Myers Squibb Company.
Category: FDA Approvals
OPDIVO® (Nivolumab) with YERVOY® (Ipilimumab)
The FDA on April 8, 2025, approved OPDIVO® with YERVOY® 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 approval to regular approval for single agent OPDIVO® for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following Fuoropyrimidine, Oxaliplatin, and Irinotecan. OPDIVO® and YERVOY® are products of Bristol Myers Squibb Company.
IMFINZI® (Durvalumab)
The FDA on March 28, 2025, approved IMFINZI® with Gemcitabine and Cisplatin as neoadjuvant treatment, followed by single agent IMFINZI® as adjuvant treatment following radical cystectomy, for adults with Muscle Invasive Bladder Cancer (MIBC). IMFINZI® is a product of AstraZeneca.
PLUVICTO® (Lutetium Lu 177 vipivotide tetraxetan)
The FDA on March 28, 2025, expanded the indication for PLUVICTO® 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. PLUVICTO® is a product of Novartis Pharmaceuticals Corporation.
CABOMETYX® (Cabozantinib)
The FDA on March 26, 2025, approved CABOMETYX® 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). CABOMETYX® is a product of Exelixis, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on March 19, 2025, granted traditional approval to KEYTRUDA® 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). KEYTRUDA® is a product of Merck.
ROMVIMZA® (Vimseltinib)
The FDA on February 14, 2025, approved ROMVIMZA®, 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. ROMVIMZA® is a product of Deciphera Pharmaceuticals, LLC.
ADCETRIS® (Brentuximab vedotin)
The FDA on February 11, 2025, approved ADCETRIS® 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 B-Cell Lymphoma (HGBL), after two or more lines of systemic therapy, who are ineligible for autologous Hematopoietic Stem Cell Transplantation (auto-HSCT) or CAR T-cell therapy. ADCETRIS® is a product of Seagen Inc., a subsidiary of Pfizer.
GOMEKLI® (Mirdametinib)
The FDA on February 11, 2025, approved GOMEKLI®, 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. GOMEKLI® is a product of SpringWorks Therapeutics, Inc.
GRAFAPEX® (Treosulfan)
The FDA on January 21, 2025, approved GRAFAPEX®, 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). GRAFAPEX® is a product of medac GmbH.