China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has secured an expanded indication approval from the European Union for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy is now approved as a second-line treatment for adults with relapsed/refractory multiple myeloma (MM) who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), have shown disease progression after the most recent treatment, and are refractory to lenalidomide.
Carvykti is being commercialized globally by Janssen Biotech, a subsidiary of Johnson & Johnson, in the US, Europe, and other markets. The drug received its first major market approvals in 2023, starting with the US in March, followed by the European Medicines Agency (EMA) in May and Japan, all for heavily pre-treated patients with relapsed/refractory MM. Carvykti is awaiting its first regulatory decision in China and has generated USD 500 million in sales in 2023 and USD 159 million in Q1 2024.- Flcube.com
