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VisitWill FDA grant full approval to afami-cel for synovial sarcoma by December 31, 2024?
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FDA official announcements and website
FDA Approves Afami-cel for Synovial Sarcoma, Advances Cosibelimab and Adagrasib-Cetuximab Therapies
Aug 12, 2024, 11:03 AM
The FDA has granted accelerated approval to afami-cel, an engineered T cell therapy, for the treatment of adults with synovial sarcoma. This marks a significant advancement in immunotherapy for solid tumors. Additionally, the FDA has accepted the Biologics License Application (BLA) for cosibelimab, a treatment for locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC), following a resubmission to address previous deficiencies. Furthermore, the FDA has also granted accelerated approval to the combination of adagrasib and cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer.
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