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News
Europe is one step closer to approving daraxonrasib (Rasonque) for metastatic pancreatic cancer. The EMA's CHMP issued a positive opinion recommending the oral RAS inhibitor for patients who've had at least one prior therapy — following its August 2026 FDA approval. The recommendation is backed by phase 3 data showing median overall survival nearly doubled vs. chemotherapy (13.2 vs. 6.7 months), with the European Commission's final decision now pending.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for daraxonrasib (Rasonque) as a monotherapy for adults with previously treated metastatic pancreatic adenocarcinoma — marking a major regulatory milestone for a drug already hailed as a game-changer in oncology. The European Commission will now make the final call, with approval expected to apply across all EU member states plus Iceland, Norway, and Liechtenstein.
The recommendation is grounded in data from the landmark phase 3 RASolute 302 trial (n = 500), which showed daraxonrasib nearly doubled median overall survival compared to chemotherapy. The drug works by binding to cyclophilin A to form a complex that blocks the active "on" state of RAS — a protein mutated in over 90% of pancreatic cancers and long considered undruggable. This follows the FDA's August 2026 approval of the same drug, which was granted 6.5 months ahead of its user fee deadline.
By the Numbers:
Why it matters: Pancreatic cancer has one of the lowest survival rates of any cancer, and second-line options have historically offered only modest benefit. Daraxonrasib's approval in both the US and now potentially Europe signals a new era of RAS-targeted therapy — with ongoing trials exploring its use in the first-line setting and in combination with chemotherapy, raising hopes for even broader impact.
