On April 20, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BBO-11818 for the treatment of adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma.
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"Receiving Fast Track designation from the FDA for BBO-11818 in KRAS-mutant pancreatic ductal adenocarcinoma reflects the importance and urgency of accelerating the development of our pan-KRAS inhibitor in this serious disease," said Yong Ben, MD, Chief Medical and Development Officer of BBOT. "Pancreatic cancer remains one of the most difficult-to-treat malignancies. KRAS mutations are present in the vast majority of cases, yet patients have had few targeted options. This designation will help us collaborate closely with the FDA to advance BBO-11818 as efficiently as possible for patients who need new options."
This designation follows preliminary data, first released in January 2026, in which BBO-11818 monotherapy demonstrated a confirmed partial response in pancreatic cancer. In addition, anti-tumor activity was observed across dose levels and tumor types with tumor reductions at higher dose levels with a generally favorable, differentiated safety profile in dose escalation.
While KRASG12C inhibitors have demonstrated promising clinical efficacy, there remains a clear unmet medical need for therapies targeting cancers that carry other KRAS mutations, such as KRASG12D and KRASG12V. BBO-11818 was developed to address this gap and is specifically designed as a potent pan-KRAS inhibitor with strong binding affinity for KRAS, high selectivity over HRAS and NRAS, and the ability to achieve high levels of KRAS inhibition in both the ON and OFF states. BBO-11818 is being evaluated as monotherapy, in combination with standard-of-care therapies, or alongside BBOT’s RAS:PI3Kα breaker, BBO-10203.
Fast Track designation is intended to help rapidly advance the development and review process for promising therapeutic candidates for serious conditions that may fill an unmet medical need.
About BBO-11818
BBO-11818 is a selective, orally bioavailable non-covalent inhibitor that targets KRAS in both the ON and OFF states, has high selectivity over HRAS and NRAS, and displays strong activity in KRAS-mutant preclinical models, including KRASG12D and KRASG12V. In addition, it potently suppresses MAPK signaling and inhibits cell proliferation in KRAS-mutant cell lines. BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors.
(Press release, BridgeBio Oncology Therapeutics, APR 20, 2026, View Source [SID1234664580])