GlobeNewswire·Aug 18, 2026, 7:00 AM ET

BlossomHill Therapeutics Announces FDA Fast Track Designation for BH-30643, a Macrocyclic OMNI-EGFR™ Inhibitor for the Treatment of Advanced EGFR C797S-positive NSCLC

BlossomHill Therapeutics announced that the FDA granted Fast Track designation to BH-30643 for adult patients with advanced or metastatic EGFR C797S-positive non-small cell lung cancer (NSCLC) following prior third-generation EGFR TKI treatment.
BH-30643 is an investigational, orally bioavailable, non-covalent, macrocyclic, brain-active, mutant-selective OMNI-EGFR inhibitor designed to overcome C797S-mediated resistance.
The drug is being evaluated in the SOLARA global Phase 1/2 first-in-human clinical trial, which enrolls patients at over 40 sites across 10 countries.
Fast Track designation facilitates more frequent FDA interactions, rolling review of New Drug Applications, and potential eligibility for Accelerated Approval if criteria are met.
No oral targeted therapies are currently approved for this specific molecularly defined population, highlighting the unmet medical need addressed by BH-30643.
BlossomHill Therapeutics is headquartered in San Diego, California, and is led by industry veteran J. Jean Cui, Ph.D.
The company's other clinical programs include BH-20236 for relapsed or refractory acute myeloid leukemia and BH-501284, a preclinical pan-KRAS Switch II inhibitor.
The press release includes standard cautionary statements regarding forward-looking statements, risks associated with clinical trials, regulatory approval, and financial requirements.