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(1) Application based on positive Phase 1b/2 data from the CARTITUDE-1 study and follows confirmation of accelerated assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency The Janssen Pharmaceutical Companies of Johnson Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory ...

Share: Phase 2 Adaptive Trial Design to Evaluate VS-6766 Alone and in Combination with Defactinib With a Focus on KRAS-G12V Mutations Trial Designed to Address Significant Unmet Medical Need in These Treatment-Resistant Tumors Verastem Oncology to Seek FDA Accelerated Approval, Pending Trial Outcome Verastem, Inc. (NASDAQ:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced the initiation of a Phase 2 registration-directed clinical trial of VS-6766, its RAF/MEK inhibitor, alone and in combinati...