60% ORR and 15-month PFS in non-classical EGFR NSCLC set up the pivotal bet — FDA alignment determines whether data converts to approval

Black Diamond Therapeutics is a clinical-stage company developing silevertinib, a targeted cancer drug for non-classical EGFR-mutant lung cancer, which is not yet approved.

Silevertinib posted 60% ORR and a preliminary 15.2-month median PFS in 43 frontline non-classical EGFR-mutant NSCLC patients, a genetically defined population historically excluded from approved TKIs. The thesis resolves on whether an FDA meeting in 2026 yields a pivotal path acceptable for approval, since the single-arm Phase 2 design leaves approvability dependent on regulatory agreement on endpoints and control. Cash through H2 2028 covers that meeting and preliminary GBM data, but a negative or inconclusive FDA response could stall pivotal initiation and force a redesign.