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FDA Updates for December 2024
On December 27, 2024, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab indications (Opdivo, Bristol Myers Squibb Company) as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib based on the CHECKMATE-67T trial (NCT04810078). The approval includes indications for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Opdivo Qvantig is not indicated in combination with intravenous ipilimumab. Read More
On December 20, 2024, the FDA granted accelerated approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test, and based on the BREAKWATER trial (NCT04607421). Read More
On December 18, 2024, the FDA approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with ALK-positive locally advanced or metastatic NSCLC who have not previously received an ALK-inhibitor based on the eXALT3 (NCT02767804) trial. Read More
On December 13, 2024, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), 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 based on the Study (NCT03212404). Read More
On December 4, 2024, the FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy based on the ADRIATIC trial (NCT03703297). Read More
On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with the following:
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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
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advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.
This represents the first FDA approval of a systemic therapy for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion and was based on the eNRGy study (NCT02912949). Read More
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