MedPage Today March 16, 2024
Charles Bankhead

— Cilta-cel, ide-cel win support despite concerns about early mortality risk

Two CAR T-cell therapies for multiple myeloma won favorable recommendations for earlier use in the disease during a day-long meeting of the FDA Oncologic Drugs Advisory Committee (ODAC).

By an 11-0 vote, ODAC recommended that FDA approve ciltacabtagene autoleucel (cilta-cel, Carvykti) for use as second-line therapy in certain patients with myeloma. Later in the day, the panel voted 8-3 in favor of approving idecabtagene ciloleucel (ide-cel, Abecma) for second-line treatment. The FDA is not bound by advisory committee decisions but usually follows the recommendations.

The favorable recommendations followed considerable discussion about an early mortality risk — and the potential cause — seen in pivotal trials of both therapies. In...

Today's Sponsors

Venturous
Got healthcare questions? Just ask Transcarent

Today's Sponsor

Venturous

Continue Reading

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
Related Articles:
FDA Approves First Biosimilar of Xolair
Opinion: STAT+: How will the Center for Biologics Evaluation and Research change under RFK Jr.?
How the FDA Opens the Door to Risky Chemicals in America’s Food Supply
FDA OKs First Gene Therapy Implant for a Rare Eye Disease
Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder

Share This Article