Black Diamond says FDA feedback clears a path to approval for silevertinib

Black Diamond Therapeutics said Nov. 10 that updated Phase 2 results for silevertinib, plus feedback from its End of Phase 2 meeting with the U.S. Food and Drug Administration, give it a route to potential accelerated and full approval in frontline non-small cell lung cancer patients whose tumors carry EGFR non-classical mutations. The Cambridge, Massachusetts-based company, which trades on Nasdaq as BDTX, disclosed the data alongside its third-quarter 2026 financial results for the period ended Sept. 30.

Clinical investigator Alex Spira, director of the Thoracic and Phase I Program at Virginia Cancer Specialists and chief scientific officer of NEXT Oncology, pointed to the CNS response rate and progression-free survival data from the trial, calling it remarkable that no frontline patient treated with silevertinib has developed de novo brain metastases. The company noted the data come from a single-arm Phase 2 trial, with no head-to-head studies run and cross-trial comparisons limited by differences in design, patient population, endpoints and dosing.

Chief Medical Officer Sergey Yurasov said the brain is the most common site of distant metastasis for patients with EGFR-mutant NSCLC, and framed silevertinib's ability to significantly delay CNS progression as the driver of the durable benefit seen in patients both with and without baseline brain metastases, and as the foundation of the pivotal program design.

CEO Mark Velleca described the FDA meeting as highly collaborative and said the feedback supports a clear path to potential accelerated and full approval. He added that EGFR non-classical mutation patients make up roughly 25% of the frontline EGFR mutant population, a group the company argues its trial design addresses differently.

Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC, and is designed to inhibit key EGFR alterations in GBM including EGFRvIII while avoiding the paradoxical EGFR activation reported with reversible TKIs. Black Diamond says more than 200 patients with EGFR-mutant NSCLC or EGFR-altered GBM have been treated with the drug to date. Beyond the Phase 2 NSCLC trial, the company is running a randomized Phase 2 study of silevertinib in newly diagnosed EGFRvIII-positive GBM, listed as NCT07326566.