Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing approval from China’s National Medical Products Administration (NMPA) for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). This therapy is intended for patients with relapsed/refractory multiple myeloma (MM) who have undergone at least third-line treatment, including the use of at least one proteasome inhibitor and immune modulator.
The approval is supported by the multi-center confirmatory Phase II CARTIFAN-1 study (NCT03758417) conducted in China. With a median follow-up of 37.29 months, the study reported an overall response rate (ORR) of 87.9% among the 58 patients treated with Carvykti. Notably, 86.2% achieved very good partial response (VGPR) or above, and 79.3% achieved complete response (CR) or stringent complete response (sCR). The median duration of response (mDOR) was 32.56 months, median progression-free survival (mPFS) was 30.13 months, and the median overall survival (mOS) has not been reached.
Carvykti’s commercialization in the US, Europe, and other global markets is managed by its partner Janssen Biotech, a subsidiary of Johnson & Johnson. The therapy received its first major market approvals in 2022, commencing 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. In the US, it was approved for the treatment of second-line R/R MM in April of this year. According to a recent financial report, the drug generated sales of USD 500 million in 2023 and USD 159 million in the fourth quarter of 2023.- Flcube.com
