MBIO - Mustang Bio CAR T cell therapy for rare blood cancer gets FDA orphan drug status

The U.S. Food and Drug Administration (FDA) granted orphan drug designation to Mustang Bio's (NASDAQ:MBIO) CAR T cell therapy MB-106 to treat Waldenstrom macroglobulinemia (WM). WM is rare cancer that begins when the bone marrow produces too many abnormal white blood cells. WM is a rare type of B-cell non-Hodgkin lymphoma (B-NHL). Mustang said in June 22 press release that MB-106 is being developed in collaboration with Fred Hutchinson Cancer Center to treat patients with relapsed or refractory B-NHLs and chronic lymphocytic leukemia (CLL). The FDA grants orphan drug status to therapies for those rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved. Mustang noted that currently no CAR T therapy is specifically approved for WM.

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Mustang Bio CAR T cell therapy for rare blood cancer gets FDA orphan drug status