FDA Approvals for Multiple Myeloma
Panelists discuss how the evolution of FDA approvals for multiple myeloma therapies reflects rapid innovation and increasing effectiveness, particularly with cell-based treatments.
The discussion shifts to the historical timeline of FDA approvals for various multiple myeloma treatments. From the early 2000s with thalidomide and lenalidomide to more recent approvals of monoclonal antibodies and chimeric antigen receptor (CAR) T-cell products, the therapeutic landscape has expanded dramatically.
CAR T-cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel have demonstrated impressive efficacy, leading to their approval even in earlier lines of treatment. This indicates a paradigm shift from salvage therapy to potentially curative intervention earlier in the disease course.
The conversation sets the stage for analyzing long-term outcomes, particularly from the CARTITUDE-1 trial. The central question revolves around whether these therapies can cure myeloma and what 5-year follow-up data reveal about durable responses and safety.
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