Silver Spring, Maryland – The FDA’s Oncologic Drugs Advisory Committee discussed the risks and benefits of CAR-T therapies developed by Johnson & Johnson, Legend Biotech, Bristol Myers Squibb, and 2seventyBio for the treatment of multiple myeloma. The committee voted in support of Carvykti and Abecma as earlier lines of treatment, despite concerns about early deaths in the trials.
During the meeting, experts evaluated the data from the trials, noting a higher rate of early deaths in the Carvykti trial. However, they ultimately decided that the benefits of the treatment, such as improved progression-free survival, outweighed the risks. Members of the committee emphasized the importance of considering the long-term benefits for patients with multiple myeloma.
Some committee members expressed reservations about the data and issues with early deaths in the Abecma trial. While there were concerns about the survival curves and response durability, experts acknowledged the significant progression-free survival difference and the potential benefits for patients. The discussion highlighted the need for in-depth conversations between patients and healthcare providers about the risks and benefits of the therapies.
Both Johnson & Johnson and Bristol Myers Squibb are seeking label expansions for their CAR-T therapies to be used in earlier lines of treatment for multiple myeloma. The companies remain confident in the trial results and are optimistic about the potential of CAR-T therapies in improving outcomes for patients with relapsed/refractory multiple myeloma.
Despite concerns raised by the FDA about the risk of secondary malignancies associated with CAR-T therapy, oncologists continue to support the use of these treatments, emphasizing their life-saving potential. Moving CAR-T therapies into earlier lines of treatment has shown promise in improving outcomes for patients, as healthier T cells may be more effective in producing CAR-T cell products.
The discussions at the FDA advisory committee meeting reflect the ongoing debate in the medical community about the use of CAR-T therapies in cancer treatment. While there are concerns about potential risks, experts remain hopeful about the benefits these innovative therapies can offer to patients with challenging-to-treat cancers. Ultimately, the decision to approve Carvykti and Abecma for earlier lines of treatment underscores the commitment to advancing treatment options for patients with multiple myeloma.