GenScipt Biotech Corp. (HKG: 1548), a China-based Contract Development and Manufacturing Organization (CDMO), through its subsidiary Legend Biotech Corporation (NASDAQ: LEGN), has announced a market approval filing in Europe for its chimeric antigen receptor (CAR)-T therapy Carvykti (ciltacabtagene autoleucel). The therapy is proposed as a second-line treatment for recurrent/refractory (R/R) multiple myeloma (MM). The filing is supported by the results of the Phase III CARTITUDE-4 study, which also underpinned a filing with the US FDA last year.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is anticipated to hold a meeting to review the study data, focusing on patients who have been previously treated with at least one therapy, including proteasome inhibitors and immunomodulators.
The European Medicines Agency (EMA)’s Committee for Advanced Therapies (CAT) will convene a Scientific Advisory Group on Oncology (SAG-O) meeting to review the filings backing the Type II mutation application. This application seeks to expand the use of Carvykti in recurrent and lenalidomide refractory MM patients who have been previously treated with first to third-line treatments.
Additionally, the FDA announced label updates for approved CAR-T therapies, including Carvykti. On November 28, 2023, the FDA announced its investigation into the severity and safety signals of T-cell malignancies found in patients receiving BCMA targeted or CD19 targeted autologous CAR-T cell immunotherapies. The FDA deemed these to be “new safety information.” However, the International Society for Cell & Gene Therapy (ISCT), a group of clinicians, researchers, regulators, technologists, and industry partners, defended these products in a statement earlier this month. On January 19, the FDA announced that new safety information should be included in the labels of all genetically modified autologous CAR-T cell immunotherapies targeting BCMA and CD19, including Carvykti.- Flcube.com
