The FDA has approved Legend Biotech Corporation's (NASDAQ:LEGN) first product, Carvykti (ciltacabtagene autoleucel; cilta-cel), for relapsed or refractory multiple myeloma.
- The approval covers adult patients who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
- Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Johnson & Johnson's (NYSE:JNJ) Janssen Biotech Inc to develop and commercialize cilta-cel in December 2017.
- Related: FDA Slams Brakes On Legend Biotech's CAR-T Therapy Trial In Lymphoma Patients.
- The treatment, Carvykti/Cilta-cel, belongs to a class of drugs known as CAR-T therapies or chimeric antigen receptor T-cell therapies.
- Legend and J&J will sell the drug in Greater China at 70-30 split in profit, and in all other countries in a 50-50 split in profit.
- Besides the U.S., Carvykti/Cilta-cel is also being reviewed by health authorities in Japan and Europe.
- Price Action: LEGN shares are up 8.59% at $42.99 during the premarket session on the last check Tuesday.
