China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy has now received an expanded indication for the treatment of relapsed/refractory multiple myeloma (r/r MM) in patients who have previously received first-line treatment or later. This makes Carvykti the first and only BCMA-targeted cell therapy approved for second-line MM treatment.
Carvykti is co-developed globally with Johnson & Johnson, a partnership established in 2017. The therapy 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. According to Legend’s recent financial report for 2023, Carvykti contributed USD 159 million in Q4 2023 sales and a total of USD 500 million for the full year, highlighting the therapy’s growing market acceptance and patient impact.- Flcube.com
