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.
Author: RR
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.
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
The FDA on January 27, 2025, approved ENHERTU® for unresectable or metastatic Hormone Receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. ENHERTU® is a product of Daiichi Sankyo, Inc.
DihydroPyrimidine Dehydrogenase (DPD) Deficiency
The FDA is providing this communication to increase awareness of recent updates to the product labeling of Capecitabine and Fluorouracil (5-FU) related to risks associated with DihydroPyrimidine Dehydrogenase (DPD) deficiency. All healthcare 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 discuss testing options for DPD deficiency with their patients.
DATROWAY® (Datopotamab deruxtecan-dlnk)
The FDA on January 17, 2025, approved DATROWAY®, a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, Hormone Receptor (HR)-positive, Human Epidermal growth factor Receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. DATROWAY® is a product of Daiichi Sankyo, Inc.
LUMAKRAS® (Sotorasib) with VECTIBIX® (Panitumumab)
The FDA on January 16, 2025, approved LUMAKRAS® with VECTIBIX® for adult patients with KRAS G12C-mutated metastatic Colorectal Cancer (mCRC), as determined by an FDA-approved test, who have received prior Fluoropyrimidine, Oxaliplatin, and Irinotecan-based chemotherapy. LUMAKRAS® and VECTIBIX® are products of Amgen Inc.