Five Prime Therapeutics' FPA144 Receives FDA Orphan Drug Status

Five Prime Therapeutics Inc FPRX revealed that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to its FPA144 for gastric cancer treatment. That included cancer of the gastroesophageal junction in patients whose tumors over express FGFR2b. According to the company, FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy.

Five Prime Therapeutics SVP and Chief Medical Officer Robert Sikorski said, "Patients with advanced gastric cancer whose tumors overexpress FGFR2b have a significant unmet medical need, and the literature suggests that they have an especially poor prognosis."

Related Link: Barclays Explains Its Bullish Call On Myriad Genetics

He continued, "The initial single-agent efficacy and safety data seen so far during the ongoing FPA144 Phase 1 study is encouraging, and we look forward to further exploring FPA144 as a potential treatment for patients with gastric cancer."

The company stated orphan drug status is granted by the FDA to products that treat rare diseases; the FDA defines rare diseases as those affecting fewer than 200,000 people in the United States.

The stock traded 1.25 percent higher to $42.58, at time of writing.