Verastem Oncology Gets FDA Fast Track Designation for Lung Cancer Drug

By Kelly Cloonan


Verastem Oncology received fast track designation from the Food and Drug Administration for a potential treatment for non-small cell lung cancer.

The biopharmaceutical company said Wednesday the designation is for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic NSCLC who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody.

NSCLC is the most common type of lung cancer, accounting for about 80% to 85% of all cases, the company said. The KRAS G12D mutation occurs in 5% of NSCLC cases, and is tougher to treat with standard therapies. The FDA has not approved any therapies specifically targeting KRAS G12D mutations in cancer, the company said.

The drug, called VS-7375, previously received FDA fast track designation for the treatment of KRAS G12D-mutated advanced or metastatic pancreatic cancer, the company said.


Write to Kelly Cloonan at kelly.cloonan@wsj.com


(END) Dow Jones Newswires

June 03, 2026 17:03 ET (21:03 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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