BOSTON — Verastem Oncology (Nasdaq: VSTM) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for its investigational therapy VS-7375, an oral KRAS G12D (ON/OFF) inhibitor. The designation covers both first-line treatment and subsequent therapy for patients with KRAS G12D-mutated locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), a form of cancer with limited treatment options and poor prognosis.
Fast Track Designation is intended to accelerate the development and review of drugs aimed at serious conditions and unmet medical needs. The KRAS G12D mutation, the most common KRAS mutation in human cancers, is found in approximately 37% of pancreatic cancer cases.
“The Fast Track Designation for VS-7375 underscores the importance of our potential best-in-class KRAS G12D (ON/OFF) inhibitor,” said Dan Paterson, president and CEO of Verastem Oncology. “Given the lack of FDA-approved treatments targeting KRAS G12D, this milestone supports our goal of bringing a much-needed therapy to patients.”
Enrollment is ongoing in the U.S.-based Phase 1/2a clinical trial, which is evaluating VS-7375 in patients with advanced solid tumors carrying the KRAS G12D mutation, including pancreatic and non-small cell lung cancers. The trial’s monotherapy dose escalation began at 400mg once daily, informed by promising results from a prior study conducted by Verastem’s partner, GenFleet Therapeutics, in China. GenFleet presented initial safety and efficacy data for the drug—known there as GFH375—at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
Verastem’s trial will continue dose escalation and move to a Phase 2 cohort to assess the safety and efficacy of VS-7375 as a monotherapy. In parallel, the company will evaluate the drug in combination with cetuximab in advanced solid tumors, with plans to potentially expand into a dedicated colorectal cancer cohort based on early results.
The company also plans to expand the trial globally as it advances development of VS-7375 in several KRAS G12D-driven cancers.
