FDA Approves RevMed’s Rasonque, First RAS(ON) Inhibitor for Pancreatic Cancer

In late August, the Food and Drug Administration approved Rasonque (daraxonrasib) for patients with pancreatic ductal adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-agent systemic therapy. The approval follows a large-scale trial of 500 participants with metastatic disease.

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The trial reported a median overall survival of 13.2 months for patients receiving daraxonrasib, compared with 6.7 months for those on standard chemotherapy. Progression-free survival was also longer in the treatment arm, and only about 1 % of participants discontinued the drug because of adverse effects. Pancreatic cancer overall has a five-year survival rate of roughly 13 %, while the metastatic form carries a five-year survival rate near 3 % — both figures cited in the source material.

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Daraxonrasib belongs to a new class of RAS(ON) inhibitors that bind mutant RAS proteins locked in the active “ON” state, directly blocking downstream growth signaling. “These inhibitors harness a naturally occurring protein in cells to create a complex with a precisely engineered, large surface area that establishes a molecular foothold on the smooth, featureless surface of RAS(ON), enabling direct inhibition of RAS in its oncogenic state,” — Smith. Why

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RevMed (formerly RevMed) began in 2014 as a natural-product chemistry firm before pivoting to oncology. The company acquired Warp Drive Bio in 2018, gaining the tri-complex inhibitor platform that enabled daraxonrasib’s development. Jan Smith, the firm’s chief scientific officer, described the discovery process: “This observation led us to the realization that we had ‘a tiger by the tail’ and needed to go after RAS itself,” — Jan Smith, RevMed’s chief scientific officer

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The company has treated more than 2,500 patients with its RAS(ON) inhibitors and plans eight phase III trials—some already completed, others ongoing or slated for launch by the end of 2026. Future work includes both broad-spectrum and mutant-selective approaches to expand treatment options for RAS-driven cancers. “We’re progressing both multi- and mutant-selective approaches to explore new potential treatment options for RAS-driven cancers,” — Jan Smith, RevMed’s chief scientific officer

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• “This observation led us to the realization that we had ‘a tiger by the tail’ and needed to go after RAS itself,” — Jan Smith, RevMed’s chief scientific officer

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• “These inhibitors harness a naturally occurring protein in cells to create a complex with a precisely engineered, large surface area that establishes a molecular foothold on the smooth, featureless surface of RAS(ON), enabling direct inhibition of RAS in its oncogenic state,” — Smith. Why

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• “We’re progressing both multi- and mutant-selective approaches to explore new potential treatment options for RAS-driven cancers,” — Jan Smith, RevMed’s chief scientific officer

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• “This research has required collaboration across multiple disciplines and organizations. Our internal team spans deep expertise in chemical biology, cancer biology, structure-based and computationally assisted drug discovery, medicinal chemistry, pharmacology, translational research and clinical oncology,” — Jan Smith, RevMed’s chief scientific officer — Jan Smith, RevMed’s chief scientific officer

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These developments mark the first FDA-approved therapy that directly targets a wide range of RAS mutations, offering a new therapeutic avenue for a disease that has long resisted targeted treatment.

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