GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the label expansion of its (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The recommendation suggests the inclusion of adult patients with relapsed and refractory multiple myeloma who have received at least one prior treatment, including an immunomodulatory agent and a proteasome inhibitor, and have shown disease progression and resistance to lenalidomide during their most recent treatment.
The recommendation is supported by the outcomes of the Phase III CARTITUDE-4 study, which is the first randomized Phase III trial to evaluate the efficacy and safety of Carvykti in multiple myeloma patients who have undergone treatments from line 1 to 3 but have relapsed and demonstrated resistance to lenalidomide. The study compared Carvykti with pomalidomide combined with bortezomib plus dexamethasone or daratumumab combined with pomalidomide plus dexamethasone.
Co-developed globally with Johnson & Johnson under a 2017 agreement, Carvykti has been approved in the US, Europe, and Japan for the treatment of adult patients with recurrent or refractory (r/r) multiple myeloma (MM) who have received at least four prior lines of treatment. A similar filing for the therapy in the second-line setting has also been submitted in the US.- Flcube.com
