European Commission Grants Orphan Drug Designation to Cabiralizumab (FPA008)

Five Prime Therapeutics, Inc. announced that the European Commission has granted orphan designation for cabiralizumab (FPA008) for the treatment of tenosynovial giant cell tumour, localised and diffuse type, also known as Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium.

“PVNS is a rare neoplastic joint disease that is driven by CSF1R signaling and can be associated with significant pain and debilitation,” said Helen Collins, M.D., vice president of clinical development, Five Prime. “Cabiralizumab is our investigational antibody that we believe could be a potential treatment for PVNS, a disease for which there are no currently approved medical treatments. This orphan drug designation in Europe highlights the need for new treatments to help patients.”

Orphan designation is assigned to a medicine intended for use against a rare condition. The medicine must fulfill certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market.