The Priority Review

Approvals Brief

CHMP adopts positive opinion on Rasonque for metastatic pancreatic cancer

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending marketing authorisation for Rasonque, a daraxonrasib monotherapy for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. The product will be available as 100 mg and 150 mg film-coated tablets and is designated as an orphan medicine.

Primary source

EMA medicine page (CHMP opinion), October 15, 2026

Rasonque (Daraxonrasib): EMA CHMP opinion

Read the source: Rasonque (Daraxonrasib): EMA CHMP opinion ema.europa.eu

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