BlossomHill Therapeutics (BLSM) said Tuesday the US Food and Drug Administration has granted fast track designation for BH-30643 in advanced or metastatic epidermal growth factor receptor C797S-positive non-small cell lung cancer following prior treatment with a third-generation EGFR tyrosine kinase inhibitor.

BH-30643 is an investigational, orally bioavailable, non-covalent, macrocyclic, brain-active, mutant-selective OMNI-EGFR inhibitor.

BlossomHill said BH-30643 is being evaluated in a global phase 1/2 first-in-human clinical trial, with patients enrolled at more than 40 sites across 10 countries.

Ongoing dose-expansion cohorts are enrolling patients in both tyrosine kinase inhibitor-pretreated and tyrosine kinase inhibitor-naive settings, the company said.

Shares of BlossomHill are up 2.9% in premarket activity Tuesday.