GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), will update the warning label for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), to account for the potential risk of myeloid neoplasms in patients treated with the drug. The updated label will incorporate additional efficacy and safety data from the long-term follow-up trial, CARTITUDE-1, which had a median duration of 28 months.
The revision to the Boxed Warning comes after it was observed that myeloid neoplasms, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or MDS followed by AML, occurred in 10% (10/97) of patients treated with Carvykti in the CARTITUDE-1 study. The median time to onset for these neoplasms was 485 days after treatment with Carvykti, ranging from 162 to 1040 days. Nine out of the ten patients who developed myeloid neoplasms died afterwards. While a causal link between Carvykti and the development of myeloid neoplasms has not been definitively established, the safety update reflects the observed data from the trial.- Fineline.com
