EMA backs EU approval of Daraxonrasib for advanced pancreatic cancer

The European Medicines Agency has issued a positive opinion on granting EU market authorization for Daraxonrasib, intended for adults with metastatic pancreatic cancer who have previously undergone at least one other therapy. The recommendation stems from an accelerated review process, reflecting the drug’s promise to fill a gap left by limited efficacy of standard chemotherapy. Revolution Medicines sells the product under the brand name Rasonque, and it already holds conditional approval in the United States for similar patients.

In a phase-III study involving 500 patients, those receiving Daraxonrasib lived a median of 12.4 months compared with 6.7 months for those on chemotherapy. The drug works by inhibiting mutated protein variants that drive tumor growth, though it is not curative. Final approval now depends on the European Commission, with the Federal Institute for Drugs and Medical Devices having participated in the assessment.