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

 
• By Sarah Karlin-Smith and Sue Sutter

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 Company) CAR-T therapy Abecma has a positive benefit-risk assessment in earlier lines of treatment for multiple myeloma, although panelists raised some concerns about the lack of

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers

AMR-Targeting Drug Secures EMA PRIME Designation

 
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Global Pharma Guidance Tracker - March 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.