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Fujifilm’s Biliary Tract Cancer Drug Granted Orphan Drug Designation

FF-10832’s novel formulation is designed to enhance anti-tumor activity by prolonging plasma half-life and improving targeted delivery to tumors.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Fujifilm’s FF-10832, an investigational liposomal formulation of gemcitabine, for the treatment of biliary tract cancer (BTC). Phase 1 study (NCT03440450) results presented at ASCO 2025 suggest FF-10832 is well tolerated and has anti-tumor activity in patients with advanced BTC. FF-10832 is currently being evaluated in phase 2a studies (NCT05318573) as monotherapy or in combination with pembrolizumab for the tr...

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