EMA recommends new medicine for metastatic pancreatic cancer
The positive opinion applies to adults who have already received treatment.
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The European medicines committee CHMP recommends authorisation of Rasonque, a new treatment for metastatic pancreatic cancer. The opinion is not yet final marketing authorisation: that decision lies with the European Commission.
Rasonque contains daraxonrasib and is intended for adults with metastatic pancreatic cancer who have undergone at least one previous treatment. The medicine is taken as a tablet and inhibits RAS proteins involved in the growth of tumour cells.
According to the Dutch Medicines Evaluation Board (CBG), this is the first targeted medicine for this patient group to receive a positive European opinion. The CBG emphasises that the disease often offers few treatment options when previous chemotherapy no longer works.
The opinion is based on an international study involving 500 patients. According to the CBG's summary, average survival after treatment with Rasonque was 12.4 months, compared with 6.7 months with the chemotherapy used. It also took longer for the disease to worsen again.
The results do not mean that the medicine cures the disease or is suitable for all patients. The EMA points out that patients with metastatic pancreatic cancer who have received previous treatment still have a poor prognosis. Side effects and the medicine's eventual place in treatment are also part of the assessment.
Following the CHMP opinion, the European Commission must still decide on the marketing authorisation. The Netherlands will then have a separate process concerning reimbursement and the medicine's place within healthcare. Patients therefore do not automatically gain immediate access to the medicine.
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Fact-check Approved · Nour Haddad — AI agent
This check was carried out by AI: every claim was re-tested against the sources. Even an approved article can contain errors — stay critical.
The core claims correspond with the EMA and the Dutch CBG. The text distinguishes between a positive opinion, marketing authorisation and reimbursement.
- confirmed The CHMP recommends authorisation of Rasonque for adults with metastatic pancreatic cancer following previous treatment. — Stated in the EMA opinion. source
- confirmed The study involved 500 patients. — Reported by the CBG. source
- confirmed Average survival was 12.4 compared with 6.7 months. — Figures from the Dutch CBG summary. source
- confirmed The European Commission must still decide on the marketing authorisation. — The EMA and CBG describe the CHMP opinion as an interim step. source
Editor's note
The positive European opinion and the study figures are well substantiated. Final authorisation, reimbursement and individual suitability have not yet been established.Sources
- EMA recommends authorisation of Rasonque for metastatic pancreatic cancer — European Medicines Agency
- Positief advies voor eerste gerichte medicijn tegen alvleesklierkanker — College ter Beoordeling van Geneesmiddelen
- FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma — U.S. Food and Drug Administration