US-based oncology company Revolution Medicines, Inc. (NASDAQ: RVMD) on Thursday said it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for RASONQUE (daraxonrasib).
The once-daily oral monotherapy is intended for adults with metastatic pancreatic adenocarcinoma previously treated with at least one systemic therapy and would become the first broad RAS-targeted option in the European Union if approved by the European Commission.
The recommendation is supported by results from the global Phase 3 RASolute 302 trial, which compared RASONQUE with investigator's choice of cytotoxic chemotherapy in previously treated metastatic PDAC.
In the intent-to-treat population, RASONQUE reduced the risk of death by 60% versus chemotherapy, with a hazard ratio of 0.40 (95% CI: 0.30–0.53; p
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