Silver Spring, Maryland – The FDA’s Oncologic Drugs Advisory Committee voted in favor of supporting the approvals of CAR-T therapies as earlier lines of treatment for multiple myeloma. Johnson & Johnson, Legend Biotech, Bristol Myers Squibb, and 2seventyBio’s therapies were discussed during the meeting, with a focus on the risks associated with early deaths in the trials.
During the meeting, committee members acknowledged the higher rate of early deaths in some of the trials, but ultimately agreed that the benefits of the treatments outweighed the risks. The improved progression-free survival (PFS) documented in the trials was a key factor in the committee’s decision to support the approvals of the CAR-T therapies.
Despite concerns raised about early deaths and data issues, the committee members saw the benefit in the PFS data for both Carvykti and Abecma. Physicians and researchers expressed optimism about the potential of the therapies in earlier lines of treatment for patients with multiple myeloma.
While some committee members had reservations about certain aspects of the data, they ultimately voted in favor of supporting the approvals of the CAR-T therapies. Companies like BMS expressed confidence in the trial results and emphasized the importance of offering new therapeutic options for patients with relapsed/refractory multiple myeloma.
The FDA has been monitoring the risks associated with CAR-T therapies, including the potential for secondary malignancies. Despite these concerns, oncologists have defended the use of CAR-T therapies, citing their potential to be lifesaving for patients. Moving CAR-T therapies into earlier lines of treatment has been seen as a promising approach by experts in the field.
Overall, the support from the FDA’s advisory committee for the approvals of CAR-T therapies represents a significant advancement in the treatment options available for patients with multiple myeloma. The decision underscores the importance of continuing to innovate in the field of oncology to improve outcomes for cancer patients.