FDA Approvals, News & Updates
Officials with the FDA have granted accelerated approval to encorafenib (Braftovi; Array BioPharma, a subsidiary of Pfizer) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test. Read More ›
Ensartinib (Ensacove; Xcovery Holdings, Inc) has been approved for use in treating adult patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. Read More ›
Officials with the FDA have approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; Bristol Myers Squibb) for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of combination therapy. Read More ›
Fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) has been approved by FDA officials for use in patients with 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, who have progressed on one or more endocrine therapies in the metastatic setting. Read More ›
On January 17, 2025, the FDA approved datopotamab deruxtecan-dlnk (Datroway; Daiichi Sankyo) for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. Read More ›
The FDA has approved sotorasib (Lumakras; Amgen) with panitumumab (Vectibix; Amgen) for adult patients with KRAS G12C–mutated metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Read More ›
Acalabrutinib (Calquence; AstraZeneca) with bendamustine and rituximab has been greenlit for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem-cell transplantation. Read More ›
Officials with the FDA have approved durvalumab (Imfinzi; AstraZeneca) for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Read More ›
Zenocutuzumab-zbco (Bizengri; Merus) has been granted accelerated approval for adults with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy or advanced, unresectable, or metastatic non–small cell lung cancer harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. Read More ›
On November 20, 2024, officials with the FDA granted accelerated approval to zanidatamab-hrii (Ziihera; Jazz Pharmaceuticals, Inc), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Read More ›