Legend Biotech Corporation, a global biotechnology company that develops, manufactures and commercializes novel therapies to treat life-threatening diseases, announced the filing of a Application for type II deviation for CARVYKTI at the European Medicines Agency (EMA) known. This application is based on data from the CARTITUDE-4 study evaluating the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. The application was submitted to the EMA by Janssen-Cilag International NV, a subsidiary of Janssen Biotech, Inc. and a partner of Legend Biotech for the development and commercialization of Cilta-Cel.
The application is based on data from the CARTITUDE-4 study, a randomized phase 3 study evaluating the efficacy and safety of Cilta-cel compared to pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd ) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. 1 CARTITUDE-4 is the first randomized phase 3 study evaluating the efficacy of cell therapy after the first relapse in multiple myeloma.
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Results from the CARTITUDE-4 study will be presented in an oral presentation at the upcoming American Society of Clinical Oncology Annual Meeting on Monday, June 5, 2023 from 9:45 a.m. to 11:15 a.m. CDT. In addition, these data will be presented as an oral presentation in a plenary session at the 2023 European Hematology Association (EHA) Hybrid Congress. It is also planned to submit an application for approval to the US Food and Drug Administration.
CARVYKTI : INDICATIONS AND USE (USA)
CARVYKTI is a B-cell maturation antigen (BCMA)-targeted, genetically modified autologous T-cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including one proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
SOURCE: Businesswire