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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...

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More from US FDA Performance Tracker

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

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

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

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

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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More from Regulatory Trackers

Global Pharma Guidance Tracker - April 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.

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

 
• By Bridget Silverman

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• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.