- The Food and Drug Administration has cleared two multiple myeloma cell therapies for earlier use treating the blood cancer, granting expanded approvals to Bristol Myers Squibb’s Abecma and to Johnson & Johnson’s Carvykti.
- The OKs come three weeks after a panel of FDA advisers agreed the benefits of earlier treatment outweighed the risks, including concerns raised by agency reviewers over data indicating an elevated chance of death among treated study participants early on in the companies’ main trials.
- Abecma, which is co-marketed by 2seventy Bio, is now available for people who previously received at least two drug regimens for their multiple myeloma, while Carvykti can be used after just one prior line of therapy. J&J developed Carvykti together with Legend Biotech.
Overall, trial results showed that both Abecma and Carvykti substantially reduced the risk of disease progression or death, compared to standard…
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