GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced that its subsidiary Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), has received a recommendation from the US FDA’s Oncologic Drugs Advisory Committee (ODAC). Following a review of the drug’s latest indication approval filing, the ODAC voted unanimously 11-0 to endorse Carvykti with a favorable risk-benefit assessment for a broader indication as a second-line therapy for adults with relapsed/refractory multiple myeloma (r/r MM).
Legend Biotech and its partner Johnson & Johnson are seeking approval for Carvykti to treat adult patients with r/r MM who have received at least one prior treatment, including an immunomodulatory agent and a proteasome inhibitor, and have disease progression while being refractory to lenalidomide. The ODAC’s decision was based on efficacy and safety data from the Phase III CARTITUDE-4 study.
Co-developed globally with Johnson & Johnson under a 2017 deal, Carvykti is already approved to treat adult patients with r/r MM who have received at least four lines of treatment in the US, Europe, and Japan. A similar filing for the therapy in the second-line setting has also been submitted in the EU. According to Legend’s recent financial report for 2023, Carvykti contributed USD 159 million in Q4 2023 sales and USD 500 million for the full year.- Flcube.com
