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.
Category: FDA Approvals
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.
CALQUENCE® (Acalabrutinib) with Bendamustine and Rituximab
The FDA on January 16, 2025, granted traditional approval to CALQUENCE® (Acalabrutinib) with Bendamustine and Rituximab for adults with previously untreated Mantle Cell Lymphoma (MCL) who are ineligible for autologous Hematopoietic Stem Cell Transplantation (HSCT). CALQUENCE® is a product of AstraZeneca.
OPDIVO QVANTIG® (Nivolumab and Hyaluronidase-nvhy)
The FDA on December 27, 2024, approved OPDIVO QVANTIG® for subcutaneous injection across approved adult, solid tumor OPDIVO® indications as monotherapy, monotherapy maintenance following completion of OPDIVO® plus YERVOY® (Ipilimumab) combination therapy, or in combination with chemotherapy or Cabozantinib. OPDIVO QVANTIG® is a product of Bristol Myers Squibb Company.
BRAFTOVI® (Encorafenib)
The FDA on December 20, 2024, granted accelerated approval to BRAFTOVI® with Cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI® is a product of Array BioPharma Inc., a subsidiary of Pfizer Inc.
ENSACOVE® (Ensartinib)
The FDA on December 18, 2024, approved ENSACOVE® for adult patients with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not previously received an ALK-inhibitor. ENSACOVE® is a product of Xcovery Holdings, Inc.
RYONCIL® (Remestemcel-L-rknd)
The FDA on December 18, 2024, approved RYONCIL®, an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy, for Steroid-Refractory acute Graft Versus Host Disease (SR-aGVHD) in pediatric patients 2 months of age and older. RYONCIL® is the first FDA-approved MSC therapy and is a product of Mesoblast, Inc.
UNLOXCYT® (Cosibelimab-ipdl)
The FDA on December 13, 2024, approved UNLOXCYT® (Cosibelimab-ipdl), a Programmed Death Ligand-1 (PD-L1) blocking antibody, for adults with metastatic Cutaneous Squamous Cell Carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT® is a product of Checkpoint Therapeutics, Inc.