LEGN - FDA To Review Two Cell Therapies For Multiple Myeloma This Week - Johnson & Johnson And Bristol-Myers | Benzinga
On Friday, 15 March, the FDA’s Oncologic Drugs Advisory Committee will meet to discuss Johnson & Johnson (NYSE:JNJ) / Legend Biotech Corporation’s (NASDAQ:LEGN) supplemental biologics license application for Carvykti (ciltacabtagene autoleucel) for relapsed or refractory multiple myeloma, who have received at least one prior line of therapy.
The panel will discuss whether the results of CARTITUDE-4 are sufficient to support a positive risk-benefit assessment of ciltacabtagene-autoleucel (cilta-cel) for the proposed indication.
Specifically, is the risk of early death associated with cilta-cel treatment acceptable in the context of the clinical benefit.
“While the cilta-cel arm demonstrates a benefit after 11 months, the finding is limited by heavy ...