News / 16 October 2026
EMA committee recommends authorisation of Rasonque for metastatic pancreatic cancer
EMA's human medicines committee (CHMP) has recommended granting an EU marketing authorisation for Rasonque (daraxonrasib), an oral treatment for adults with metastatic pancreatic adenocarcinoma who have received at least one previous treatment.[1] The opinion will now be sent to the European Commission, which will fast-track its decision on an EU-wide marketing authorisation.[1]
The applicant for Rasonque is Revolution Medicines.[1] The recommendation follows a phased review, in which the CHMP evaluated quality, non-clinical and clinical data in phases as the company submitted them.[1] The review started in early July 2026 and took less than 150 days, while maintaining the standards for quality, safety and effectiveness.[1] By comparison, a standard evaluation can take up to 210 active days and usually takes around a year overall, including time for the company to respond to questions.[1]
Rasonque was investigated in an open-label, phase 3, multinational study involving 500 patients whose metastatic pancreatic adenocarcinoma had worsened after prior systemic treatment.[1] Of these patients, 92% had a confirmed RAS G12 mutation.[1] Patients treated with Rasonque lived for a median of 12.4 months, compared with 6.7 months for those treated with chemotherapy.[1] The median time patients lived without their disease worsening was 7.2 months with Rasonque and 3.6 months with chemotherapy.[1]
The most common side effects reported with Rasonque were diarrhoea, rash, stomatitis, nausea and vomiting.[1] The overall survival analysis used data collected up to 15 June 2026, and the progression-free survival analysis used data collected up to 10 February 2026.[1]
The CHMP opinion is an intermediary step on the path to patient access.[1] Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State.[1]
Background
Rasonque was identified under EMA's Cancer Medicines Pathfinder project as a high-priority medicine that could address an unmet medical need.[1] Daraxonrasib was designated an orphan medicinal product for the treatment of pancreatic cancer on 20 April 2026.[1]
This article summarises an official publication for learning purposes. It is not investment advice and makes no forecast of prices or outcomes. Read the original source before relying on any detail.
Sources
- European Medicines Agency. EMA recommends authorisation of Rasonque for metastatic pancreatic cancer. Published 2026-10-15. Read the source
Checked 16 October 2026. How we check sources