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.
Category: FDA Approvals
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.
IMFINZI® (Durvalumab)
The FDA on December 4, 2024, approved IMFINZI® for adults with Limited-Stage Small Cell Lung Cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. IMFINZI® is a product of AstraZeneca.
BIZENGRI® (Zenocutuzumab-zbco)
The FDA on December 4, 2024, granted accelerated approval to BIZENGRI® for adults with the following:
Advanced, unresectable, or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring a Neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or
Advanced, unresectable, or metastatic Pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.
BIZENGRI® is a product of Merus N.V.
ZIIHERA® (Zanidatamab-hrii)
The FDA on November 20, 2024, granted accelerated approval to ZIIHERA®, a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. ZIIHERA® is a product of Jazz Pharmaceuticals, Inc.