Revolution Medicines' Daraxonrasib Succeeds in Phase 3 Trial for Pancreatic Cancer
Revolution Medicines announced that its targeted pill daraxonrasib met primary and secondary endpoints in a Phase 3 trial for metastatic pancreatic cancer patients. The drug extended median survival to 13.2 months compared to 6.7 months with chemotherapy and reduced the risk of death by 60%. The company plans to seek FDA approval using a priority review voucher.
StatRevolution Medicines reported positive results from a Phase 3 trial of its drug daraxonrasib for patients with metastatic pancreatic cancer. The trial involved individuals whose cancer had progressed after prior treatment. The drug met all primary and secondary endpoints, showing improved survival outcomes compared to chemotherapy.
7 months for those on chemotherapy. The treatment reduced the risk of death by 60%. Revolution Medicines described the results as practice-changing for a disease with limited treatment options.
Trial Details and Mechanism Daraxonrasib is a daily oral pill that targets RAS mutations, which are present in about 90% of pancreatic cancer cases and roughly 30% of all human cancers.
The trial compared the drug to standard chemotherapy in patients with advanced disease. No new safety concerns emerged, though rash is a known side effect that is generally manageable. The company conducted the study in patients requiring second-line treatment.
A separate Phase 3 trial is underway for newly diagnosed patients. Pancreatic cancer has the lowest five-year survival rate among major cancers, at 13%.
Approval Plans Revolution Medicines plans to submit data to the FDA for approval soon.
The company holds a Commissioner's National Priority Review Voucher, which allows for review in one to two months. This program accelerates evaluation of certain drugs. A spokesperson for the company stated that the focus is on bringing the treatment to patients quickly.
Story Timeline
4 events- Apr 13, 2026
Revolution Medicines announced Phase 3 trial success for daraxonrasib in pancreatic cancer.
3 sourcesSTAT · CNBC · @statnews - October 2025
Replimune resubmitted its skin cancer treatment for FDA accelerated approval.
1 sourceSTAT - Recent — unspecified
FDA rejected Replimune's experimental skin cancer treatment for the second time.
1 sourceSTAT - Last week
Former Sen. Ben Sasse shared experience with daraxonrasib side effect in interview.
1 sourceCNBC
Potential Impact
- 01
FDA reviews daraxonrasib within months using priority voucher.
- 02
RAS-targeted therapies expand options for 30% of human cancers.
- 03
Ongoing Phase 3 trial tests daraxonrasib in newly diagnosed patients.
- 04
Revolution Medicines seeks approval for second-line pancreatic cancer treatment.
- 05
Debate continues on FDA standards for combination immunotherapies like Replimune's.
- 06
Revolution Medicines stock rises over 30% post-trial announcement.
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