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Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to FPA144 for the treatment of gastric cancer, including cancer of the gastroesophageal junction in patients whose tumors overexpress FGFR2b. FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy.
"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," said Robert Sikorski, M.D., Ph.D., senior vice president and chief medical officer. "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."
Globally, gastric cancer is the sixth most common malignancy with the third highest mortality. The prevalence of gastric cancer worldwide is approximately 1.5 million patients, of which an estimated 5%, or approximately 80,000 patients, have FGFR2 gene-amplified tumors that overexpress FGFR2b. There are an estimated 76,000 gastric cancer patients in the United States, but the prevalence of gastric cancer is much higher in Asia and other regions of the world.
FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy for tumors that over-express FGFR2b, as determined by a proprietary immunohistochemistry (IHC) diagnostic assay.
