Becker's Healthcare March 15, 2024
Ashleigh Hollowell

After the FDA questioned the safety of two CAR-T therapies, members of the agency’s Oncologic Drugs Advisory Committee voted unanimously to recommend Carvykti, made by Janssen Biotech, and voted 8-3 in favor for Abecma, from Bristol-Myers Squibb K.K.

Carvykti is now recommended by the panel, for “treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent and who are refractory to lenalidomide,” according to a March 15 news release from Janssen.

“As a physician and researcher committed to advancing patient care, the potential of Carvykti in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma,” Jordan...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
FDA Approves Third Tocilizumab Biosimilar
The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its Clinical Decision Support Guidance
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

Share This Article