On August 18, 2026 BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BH-30643 for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC) after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). BH-30643 is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial enrolling patients at more than 40 sites in 10 countries.
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"Fast Track designation is an important regulatory milestone and reflects FDA’s recognition, based on its review of our preliminary data, of the potential for BH-30643 to address a significant unmet medical need in this molecularly defined population, for which no oral targeted therapies are approved," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "Receiving this designation reaffirms our confidence in the development strategy for BH-30643 as a novel EGFR inhibitor designed to overcome C797S-mediated resistance. It also provides opportunities for more frequent engagement with FDA and potential access to other expedited programs, including potential eligibility for rolling review and accelerated approval, if applicable criteria are met."
The FDA’s Fast Track process was designed to bring new medicines to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with FDA regarding all aspects of a designated drug’s clinical development program, as well as for rolling review of a New Drug Application (NDA), meaning that completed sections may be submitted and reviewed on an ongoing basis rather than upon completion of the entire application. Fast Track–designated programs may also be eligible for Accelerated Approval and Priority Review if the applicable criteria for those programs are met. For more information on the Fast Track process, please visit the FDA’s official website.
About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain-active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories – classical activating mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions – while maintaining marked selectivity over wild-type EGFR. BH-30643 is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial spanning more than 40 sites in 10 countries. Ongoing dose expansion cohorts are enrolling in both TKI-pretreated and TKI-naïve settings, including a C797S resistance cohort. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).
(Press release, BlossomHill Therapeutics, AUG 18, 2026, View Source [SID1234670219])