Posted by Michael Wonder on 22 Feb 2017
Lead cancer immunotherapy candidate receives FDA fast track designation
21 February 2017 - Cell Medica today announced the U.S. FDA has granted fast rrack designation to its lead oncology product CMD-003 for patients with relapsed/refractory lymphoma and post-transplant lymphoproliferative disease associated with the oncogenic Epstein Barr virus.
CMD-003, also known as baltaleucel-T, is an investigational therapy in which the patient’s T cells are activated to kill malignant cells expressing EBV antigens. The product has the potential to address a range of Epstein Barr virus (EBV)-associated lymphomas, nasopharyngeal carcinoma and gastric cancer. The FDA fast track designation follows orphan drug designations from both the FDA (EBV-associated non-Hodgkin lymphoma) and European Commission (extranodal NK/T lymphoma, nasal type and post-transplant lymphoproliferative disease).
