The U.S. Food and Drug Administration granted Fast Track Designation to Verastem Oncology’s investigational KRAS G12D inhibitor VS‑7375 for the treatment of KRAS G12D‑mutated non‑small cell lung cancer (NSCLC).
The designation applies to adult patients with unresectable locally advanced or metastatic NSCLC who have received platinum‑based chemotherapy and an anti‑PD‑(L)1 antibody.
VS‑7375 previously received Fast Track for KRAS G12D‑mutated pancreatic cancer in July 2025.
VS‑7375 is an oral selective KRAS G12D inhibitor that binds both active and inactive KRAS G12D states.
Phase 1/2 TARGET‑D 101 trial started June 2025; early data expected in the first half of 2026, mature data in the second half of 2026.
Phase 2 TARGET‑D 202 open‑label study evaluates VS‑7375 at 900 mg once daily in patients who have received one to two prior therapy lines.
March 2026 data from TARGET‑D 101 (23 patients, doses 400‑900 mg) showed the drug was generally well tolerated, with no drug‑related liver function test abnormalities or Grade > 2 neutropenia as of the 30 January 2026 data cutoff.
NSCLC represents roughly 80‑85 % of all lung cancer cases; the KRAS G12D mutation occurs in about 5 % of NSCLC patients, affecting more than 8,000 patients in the United States each year.
No FDA‑approved therapies currently target KRAS G12D mutations.
Following the announcement, Verastem’s shares rose approximately 4 % in after‑hours trading on Wednesday.
