Rasonque (Daraxonrasib)

Where it stands

Rasonque (daraxonrasib), from Revolution Medicines Netherlands B.V., has received a positive CHMP opinion in the EU, dated 2026-10-15. The record status is "Opinion", and no approval date is recorded. In other words, the European Commission has not yet issued its marketing authorisation decision as far as these records show.

The proposed indication is treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. The therapeutic area is listed as pancreatic neoplasms.

The same substance is already approved in the US under the name Rasonque. The FDA approval is dated 2026-08-26, which is roughly seven weeks before the CHMP opinion.

Regulatory pathway and designations

In the EU, the product carries an orphan designation. The CHMP opinion is the scientific recommendation. A CHMP positive opinion is normally followed by a legally binding European Commission decision, which applies across the EU/EEA. The records give an expected EC decision date of 2026-12-21, calculated as the CHMP opinion date plus 67 days, the standard Commission decision period. This is an estimate, not an official date, and the actual timing could differ.

In the US, the records show approval under NDA220910, classed as a new molecular entity, with priority review, and the formulation is a tablet. Priority review is a US FDA designation that shortens the target review clock. The records do not state whether any expedited EU pathway (for example accelerated assessment or conditional marketing authorisation) was used, so none should be assumed.

Records do not specify whether the EU orphan designation will be maintained at the time of authorisation. In general, orphan status is reviewed at the time of marketing authorisation. This is general procedure and not a statement about this product.

Safety and pharmacovigilance

The records contain no safety data. They include no adverse event profile, contraindications, warnings, risk management plan details, or post-authorisation safety commitments for either the EU or the US.

As a general point, a product approved in the EU is expected to have a risk management plan and routine pharmacovigilance obligations. Specific measures for Rasonque cannot be described from these records. The product information adopted with the CHMP opinion and the US label would be the primary sources to review.

What to watch

The key near-term event is the European Commission decision, estimated for 2026-12-21. This is a calculated estimate only, and readers should confirm against the official Union Register of medicinal products once it is updated.

Other points to verify from primary sources: the final EU wording of the indication compared with the US label, whether any conditions or specific obligations attach to the authorisation, and whether orphan status is maintained. The records do not cover these items, nor do they cover pricing, reimbursement or launch timing in EU member states.