Silver Spring, Maryland – FDA’s Oncologic Drugs Advisory Committee recently voted to support the approvals of CAR-T therapies – Johnson & Johnson and Legend Biotech’s Carvykti and Bristol Myers Squibb and 2seventyBio’s Abcema – as earlier lines of treatment for multiple myeloma. The committee’s decision came after discussing the risks of early death in the trials of these treatments, ultimately concluding that the benefits outweighed the risks.
During the advisory committee meeting, concerns were raised regarding the higher rate of early deaths in the trial of Carvykti. However, committee members unanimously agreed that the risks did not outweigh the benefits of the treatment, particularly noting the improved progression-free survival (PFS) documented in Carvykti’s Cartitude-4 trial. Experts like William Gradishar, chief of hematology/oncology at the Robert H. Lurie Comprehensive Cancer Center, emphasized the compelling long-term PFS and overall survival findings as factors in their decision to support the therapy.
While the FDA briefing document on Abecma’s KarMMA-3 trial also highlighted a higher rate of early deaths in the treatment arm, the advisory committee voted 8-3 in favor of its approval. Despite some concerns raised by committee members regarding the data and issues with early deaths, many saw the benefit in the PFS data. Christopher Lieu from the University of Colorado, for example, acknowledged the therapy’s significant PFS difference and its potential to offer patients a chance of significant time off therapy with quality of life improvements.
The FDA has been conducting investigations into the risks associated with CAR-T therapies, including the potential for secondary malignancies. Despite these probes and the addition of boxed warnings to CAR-T therapies, oncologists have remained optimistic about the life-saving potential of these treatments. David Porter from Penn Medicine’s Abramson Cancer Center expressed support for moving CAR-T therapies into earlier lines of treatment, citing the historical effectiveness of such approaches.
Overall, the decisions by the FDA’s advisory committee to support the approvals of Carvykti and Abcema as earlier lines of treatment for multiple myeloma reflect a growing confidence in the potential of CAR-T therapies in improving patient outcomes. Experts and industry leaders continue to advocate for the expansion of these treatments, emphasizing the importance of balancing risks and benefits for patients.