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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.

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3 sources·Apr 13, 9:15 AM·1m read
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Revolution 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.

13.2 months for those on daraxonrasib compared to 6.7 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.

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%.

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. The company stated that the focus is on bringing the treatment to patients quickly.

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