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Verastem Oncology Announces U.S. FDA Fast Track Designation for VS-7375, an Oral and Potential Best-in-Class Investigational KRAS G12D (ON/OFF) Inhibitor for the Treatment of KRAS G12D-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

$VSTMPress releaseJun 3, 2026, 4:01 PM ETRead the release

Verastem Oncology announced that the FDA has granted Fast Track Designation to VS-7375 for the treatment of KRAS G12D-mutated non-small cell lung cancer (NSCLC). This designation expands the regulatory pathway for VS-7375 beyond its previously granted Fast Track status for pancreatic cancer, targeting a large patient population with limited treatment options.

Key figures

Drug Name
VS-7375
Phase Of Trial
Phase 2
Target d 202 dose
900 mg once daily
Nsclc total prevalence
80-85%
Nsclc kras g12d prevalence
5%
Us annual kras g12d diagnoses
8,000
Target d 101 max dose evaluated
1200 mg once daily

AI analysis

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    VSTM: Verastem Oncology Announces U.S. FDA Fast Track Designation for VS-7375, an Oral and Potential Best-in-Class Investigational KRAS G12D (ON/OFF) Inhibitor for the Treatment of KRAS G12D-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer — AI Analysis | Signal8