Shots:
- The EMA’s CHMP has adopted a positive opinion recommending marketing authorization of Revolution Medicines’ Rasonque (daraxonrasib) once-daily oral tablets as monotherapy for adults with metastatic pancreatic adenocarcinoma (PDAC) who have received ≥1 prior systemic therapy; if approved by the EC, it would be the first broad RAS-targeted treatment option in the EU for these pts
- Opinion is based on the global, randomized P-III (RASolute 302) trial vs investigator’s choice of cytotoxic chemotherapy, which met all 1EPs & key 2EPs in both the RAS G12-mutant and ITT populations; in ITT, Rasonque reduced the risk of death by 60% (HR: 0.40), with mOS of 13.2 vs 6.7mos. and mPFS of 7.2 vs 3.6mos. (HR: 0.49)
- The opinion follows an expedited phased review under EMA’s Cancer Medicines Pathfinder project; Rasonque, an oral RAS(ON) multi-selective, noncovalent tri-complex inhibitor, holds EU orphan designation for pancreatic cancer and was approved by the US FDA on Aug 26, 2026
Ref: Revolution Medicines | Image: Revolution Medicines | Press Release
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