Immunomedics’s myeloma drug granted orphan designation

The designation allows the company to have seven year market exclusivity for milatuzumab in multiple myeloma upon final approval by the FDA. Other financial benefits and incentives include waiver of Prescription Drug User Fee Act (PDUFA) filing fees, tax credits for the costs of clinical research, and assistance in clinical research study designs.

Cynthia Sullivan, president and CEO, said: “We are pleased to receive orphan drug designation for milatuzumab. We have initiated Phase I/II studies to evaluate the therapeutic potential of milatuzumab in patients with multiple myeloma, non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.”