Revolution Medicines' pancreatic cancer drug succeeds in late-stage Phase 3 trial

Revolution Medicines said its oral drug daraxonrasib met all primary and secondary endpoints in a Phase 3 trial, with median survival of 13.2 months versus 6.7 months for chemotherapy; the company said it will seek FDA review using a priority voucher.

Revolution Medicines announced that its oral drug daraxonrasib succeeded in a Phase 3 trial for pancreatic cancer. The company reported the drug met all primary and secondary endpoints and extended median overall survival in the tested group. Pancreatic cancer is an aggressive disease with a low five-year survival rate, and RAS mutations drive most cases. The article quotes the company leadership saying they plan to seek expedited FDA review and continue additional trials. Key facts: - The company said daraxonrasib produced a median overall survival of 13.2 months versus 6.7 months for chemotherapy in the trial it reported. - Revolution Medicines reported a 60% reduction in the risk of death versus chemotherapy, and said the drug met all primary and secondary endpoints. - The company described the drug as broadly targeting RAS mutations, which are present in about 90% of pancreatic cancer cases. - The article reports the company described the safety profile as manageable and noted rash as a known side effect; no new safety concerns were reported in the release. - The company plans to seek FDA approval for second-line use using a Commissioner's National Priority Voucher, and it is conducting a Phase 3 trial in newly diagnosed patients. Summary: The company reported results that, if reviewed by regulators, could change available treatment options for some people with pancreatic cancer. Revolution Medicines plans to pursue FDA review using a priority voucher for second-line approval while continuing a Phase 3 trial in first-line patients. Further regulatory review and ongoing trial data will determine next steps.