FDA Advisory Committee Unanimously Supports Approval of CAR-T Therapies for Multiple Myeloma

Silver Spring, Maryland – The FDA’s Oncologic Drugs Advisory Committee has recently voted on the approvals of CAR-T therapies Carvykti and Abecma as earlier lines of treatment for multiple myeloma. There were concerns raised about the risks of early death in the trials, but ultimately, the committee decided in favor of the approvals. During the meeting, members of the committee discussed the data from the trials, noting higher rates of early deaths in some cases. …

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FDA Panel to Discuss Johnson & Johnson and Legend Biotech’s CAR-T Therapy for Multiple Myeloma Risk-Benefit Assessment

Silver Spring, Maryland – The FDA’s Oncologic Drugs Advisory Committee is set to convene on Friday, March 15th, to deliberate on Johnson & Johnson’s supplemental biologics license application for Carvykti, developed by Legend Biotech Corporation, to treat relapsed or refractory multiple myeloma patients. The focus of the meeting will be on evaluating the results of the CARTITUDE-4 study and determining if the benefits of Carvykti outweigh the risks for the proposed indication. Of particular concern …

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