Verastem said the U.S. FDA granted Fast Track designation to VS-7375, its oral KRAS G12D inhibitor, for adults with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer after prior platinum-based chemotherapy and anti-PD-(L)1 treatment.

Verastem Oncology said the U.S. Food and Drug Administration granted Fast Track designation to VS-7375, its oral KRAS G12D (ON/OFF) inhibitor, for adults with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer.

The company said the designation applies to patients who had previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody. Verastem disclosed the update in a news release on June 3.

Why it matters

Fast Track designation is intended to speed development and regulatory review of therapies for serious conditions with unmet medical need. For Verastem, it adds an FDA regulatory milestone to a program that is already in clinical development.

Verastem’s pipeline and the ClinicalTrials.gov record for VS-7375 show the drug remains in active study in KRAS G12D-mutated solid tumors, including non-small cell lung cancer.

The company has described VS-7375 as an investigational oral KRAS G12D inhibitor. No separate public FDA posting of the designation was identified in the research provided.

What comes next

The announcement does not include new efficacy data or an updated development timeline. The immediate focus remains on the ongoing clinical program and any future trial updates Verastem releases.

Revision note

Initial automated publication.