FDA Approves JNJ-Legend Biotech Partnered Blood Cancer Therapy

The FDA has approved Legend Biotech Corporation's 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 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.