Cell Medica Granted FDA Fast Track Designation for Lymphoma Immunotherapy

Cell Medica received an FDA fast track designation for its cancer immunotherapy, CMD-003, developed for lymphoma patients. Also known as baltaleucel-T, the therapy uses a patient’s activated donor T cells to kill malignant cells expressing certain antigens.

The product previously received Orphan Drug designations from the FDA, in non-Hodgkin lymphoma related to the Epstein-Barr Virus, and the European Commission, for certain lymphomas, and post-transplant disease.

CMD-003 is currently being investigated in an open-label Phase II clinical trial for patients with a type of non-Hodgkin lymphoma. A separate Phase II trial will examine the therapy in patients with EBV-associated diffuse large B cell lymphoma, Hodgkin lymphoma, and post-transplant lymphoproliferative disease.