FDA Grants Fast Track Designation to BH-30643 in EGFR C797S+ NSCLC

The FDA has granted fast track designation to BH-30643, BlossomHill Therapeutics' investigational, macrocyclic OMNI-EGFR™ inhibitor, for the treatment of adult patients with advanced or metastatic EGFR C797S-positive non–small cell lung cancer (NSCLC) after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI).¹

The designation was based on the FDA's review of preliminary data supporting BH-30643's potential to address a significant unmet medical need in this molecularly defined population, for which no oral targeted therapies are currently approved. Fast track–designated programs are eligible for more frequent interactions with the FDA, rolling review of a new drug application, and potential accelerated approval and priority review if applicable criteria are met.

"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. Receiving this designation reaffirms our confidence in the development strategy for BH-30643 as a novel EGFR inhibitor designed to overcome C797S-mediated resistance,” said Geoff Oxnard, MD, chief medical officer of BlossomHill Therapeutics, in a news release.

Trial Design

BH-30643 is being evaluated in SOLARA (NCT06706076), a global, open-label, multicenter, first-in-human phase 1/2 trial assessing the safety, tolerability, pharmacokinetics, and antitumor activity of BH-30643 in adults with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations.^1,2 The trial is enrolling at more than 40 sites in 10 countries, with ongoing dose-expansion cohorts in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. Preliminary findings from the dose-escalation portion, presented in October 2025, showed antitumor activity across a range of advanced EGFR-mutant NSCLC cases with complex, difficult-to-treat resistance mutations.³

About BH-30643

BH-30643 is a noncovalent, macrocyclic, brain-active, mutant-selective OMNI-EGFR inhibitor designed to overcome the limitations of currently approved EGFR inhibitors. In preclinical studies, the agent showed potent inhibitory activity across diverse EGFR mutation categories, including classical activating mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations, and exon 20 insertions, while maintaining selectivity over wild-type EGFR.¹

REFERENCES

1. BlossomHill Therapeutics Announces FDA Fast Track Designation for BH-30643, a Macrocyclic OMNI-EGFR™ Inhibitor for the Treatment of Advanced EGFR C797S-positive NSCLC. News release. BlossomHill Therapeutics, Inc. August 18, 2026. Accessed August 19, 2026. https://tinyurl.com/3fcpfhbh

2. A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects with Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA). ClinicalTrials.gov. Accessed August 19, 2026. https://clinicaltrials.gov/study/NCT06706076

3. BlossomHill Therapeutics Presents Preliminary Findings from Phase 1/2 SOLARA Trial of BH-30643 in EGFR-mutant NSCLC at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. News release. BlossomHill Therapeutics, Inc. October 24, 2025. Accessed August 19, 2026. https://tinyurl.com/4hk2undh