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The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews

 
• By Sue Sutter

Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for myelodysplastic syndromes and supplemental applications for the CAR-T products Carvykti and Abecma in earlier lines of multiple myeloma.

Dogs barking
Even though FDA briefing documents were skeptical, the proverbial dog did not bark at ODAC, where three drugs had a smooth passage. • Source: Shutterstock

With the release of fairly negative US Food and Drug Administration briefing documents two days prior, it appeared that three sponsors would encounter challenging reviews when their products went before the Oncologic Drugs Advisory Committee on 14-15 March.

Yet, when it came time to vote on the benefit-risk assessments, ODAC members made clear they saw things differently than the skeptical FDA review staff and highlighted the benefits provided by the three agents, including success on clinically meaningful

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