The Center for Drug Evaluation (CDE) website indicates that a market approval filing from Legend Biotech Corporation (NASDAQ: LEGN) for its BCMA-directed chimeric antigen receptor (CAR) T cell therapy Carvykti (ciltacabtagene autoleucel) has been accepted for review. This makes Carvykti the third BCMA CAR-T therapy to be filed for marketing in China, following those from IASO Bio/Innovent and CARsgen Therapeutics.
Global Development and Approvals
Carvykti, co-developed by Janssen, was the focus of a global licensing deal in December 2017 between Janssen and Legend for the treatment of multiple myeloma (MM). The drug was approved by the US FDA in February 2022 and granted conditional marketing authorization by the European Commission in May of the same year. Further approval was secured in Japan in September. The drug’s first approved global indication is for fifth-line or later use in relapsed or refractory multiple myeloma.
Sales and Manufacturing Expansion
Carvykti generated USD 24 million in sales during the second quarter of 2022 and USD 55 million in the third quarter. Legend, expecting sales to peak at USD 5 billion, invested USD 250 million to ramp up manufacturing capacities for the product at its New Jersey plant. This strategic investment positions Legend to meet the growing demand for Carvykti as it expands its market presence globally.-Fineline Info & Tech
