‘The Run Is Worth The Slide:’ FDA Advisors Urge Expansion Of J&J’s CAR-T Carvykti Despite Initial Upfront Treatment Risks

Oncologic Drugs Advisory Committee also favors earlier use of Bristol-Myers Squibb’s Abecma in multiple myeloma, although some members raise concerns about lack of plateau in progression-free survival benefit and equivocable overall survival data.

an older man and woman happily slide down a playground slide — Early treatment risks are outweighed by possibility of prolonged period of durable response, ODAC says of J&J's CAR-T in earlier lines of multiple myeloma treatment. • Source: Shutterstock

US Food and Drug Administration advisors voted unanimously in favor of expanding the use of Janssen Biotech Inc.’s CAR-T Carvykti to earlier lines of multiple myeloma treatment, saying the benefit of a potential long durable response that allows patients time off toxic treatment outweighs the upfront risks of treatment initiation.

In a separate 8-3 vote, the Oncologic Drugs Advisory Committee also voted that Celgene Corporation's (Bristol Myers Squibb...