India, April 21 -- BridgeBio Oncology Therapeutics, Inc. (BBOT) said the U.S. Food and Drug Administration has granted Fast Track designation to BBO-11818 for the treatment of adults with advanced KRAS-mutant pancreatic ductal adenocarcinoma.
The designation follows preliminary data released in January 2026, in which BBO-11818 monotherapy showed a confirmed partial response in pancreatic cancer patients.
The company said anti-tumor activity was observed across dose levels and tumor types, with tumor reductions at higher doses and a generally favorable and differentiated safety profile during dose escalation.
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BBO-11818 is currently being evaluated in the...