The U.S. Food and Drug Administration has granted Fast Track Designation to Verastem Oncology’s (NASDAQ:VSTM) VS-7375, an oral KRAS G12D inhibitor, for the treatment of pancreatic cancer with KRAS G12D mutations, the company announced Thursday.
The designation applies to VS-7375 for first-line treatment of locally advanced or metastatic pancreatic adenocarcinoma with KRAS G12D mutations, as well as for patients who have received at least one prior line of standard therapy. With a strong liquidity position and cash reserves exceeding its debt obligations, Verastem appears well-positioned to advance its clinical programs.
Enrollment is currently ongoing in a U.S. Phase 1/2a clinical trial evaluating VS-7375 in patients with advanced KRAS G12D mutant solid tumors, including pancreatic cancer. The company plans to expand the trial globally.
"The Fast Track Designation for VS-7375 underscores the importance of our potential best-in-class KRAS G12D inhibitor," said Dan Paterson, president and chief executive officer of Verastem Oncology, in the press release.
The KRAS G12D mutation is the most prevalent KRAS mutation in human cancers, occurring in 37% of pancreatic cancers. Currently, no FDA-approved therapies specifically target KRAS G12D mutations.
The monotherapy dose escalation phase of the U.S. study began at a 400mg daily dose based on efficacy data from a Phase 1/2 study conducted in China by Verastem’s partner, GenFleet Therapeutics. GenFleet presented initial safety and efficacy results from its study at the 2025 American Society of Clinical Oncology Annual Meeting.
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