Verastem Oncology, a biopharmaceutical company focused on developing treatments for RAS/MAPK pathway-driven cancers, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to their oral KRAS G12D (ON/OFF) inhibitor, VS-7375. This designation applies to the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic pancreatic adenocarcinoma (PDAC), as well as those who have already undergone at least one prior line of standard systemic therapy. The Fast Track Designation is a significant step that aims to facilitate the development and expedite the review of new drugs intended to address serious conditions and fulfill unmet medical needs. This development is particularly crucial given the lack of FDA-approved treatments specifically targeting the KRAS G12D mutation, which is prevalent in a significant portion of pancreatic cancers. Verastem continues enrollment in its U.S. Phase 1/2a clinical trial and plans to expand globally, with the goal of accelerating the development of VS-7375 for advanced solid tumors.
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