Rasonque (daraxonrasib)

Where it stands

In the US, Rasonque (daraxonrasib), from Revolution Medicines, is recorded as approved. The FDA approval is dated 2026-08-26 under NDA220910. The product is a tablet. The records do not state the therapeutic area or the approved indication, so this analysis cannot describe the labelled patient population or use.

In the EU, the records show a CHMP positive opinion dated 2026-10-15, listed as official. The applicant is Revolution Medicines Netherlands B.V., and the entry is tagged Orphan. The record's header field for the CHMP opinion date shows "-", which does not match the milestone entry. Readers should confirm the opinion date against the EMA's published CHMP outputs before relying on it.

The European Commission decision is not yet recorded. The only entry is an estimated date of 2026-12-21, calculated as the CHMP opinion plus 67 days. The records explicitly say this is not an official date.

Regulatory pathway and designations

The FDA record lists two designations: New molecular entity and Priority review. New molecular entity means the active substance had not previously been approved in the US. Priority review is an FDA review classification that sets a shorter target review timeline than standard review. The records give no submission or filing dates, so the actual review timeline cannot be reconstructed from them.

In the EU, the CHMP milestone carries an Orphan tag. In general, this indicates the product is associated with orphan medicinal product status. The records do not say which condition the designation covers, or whether the status will be maintained at the time of marketing authorisation. They also do not say which EU procedure was used, such as accelerated assessment or conditional approval.

Procedurally, a CHMP positive opinion is a recommendation, not an authorisation. The European Commission normally adopts a legally binding decision within about 67 days, which is the basis of the estimated December 2026 date. Once the Commission decides, the product would be authorised across EU Member States.

Safety and pharmacovigilance

The records contain no safety information. They include no label warnings, boxed warning, adverse event data, risk management plan, REMS, post-marketing requirements or commitments, or conditions attached to either the FDA approval or the CHMP opinion.

As a new molecular entity, the product would normally be subject to routine pharmacovigilance after approval. In the EU, new active substances are generally subject to additional monitoring. These are general statements about the regulatory framework, not findings from the records. Safety conclusions require the FDA label and the EU product information, including the CHMP assessment report once published.

What to watch

The main near-term event is the European Commission decision following the 2026-10-15 CHMP positive opinion. The estimated date is 2026-12-21, but it is only an estimate and the actual date could differ. A decision would confirm the final EU indication wording, the orphan status and any conditions of authorisation.

Also watch for publication of the full US prescribing information and the EMA's product information and assessment report. These would clarify the missing indication, the therapeutic area, the safety profile and any post-marketing obligations.

The records also show the same substance as Rasonque in the EU at the opinion stage. Confirm that the EU and US product names, indications and applicant entities line up in the final documents.