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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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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