EMA backs Rasonque for metastatic pancreatic cancer in under 150 days

• 2026-10-16
• News
• News Desk
• Source: European Medicines Agency https://www.ema.europa.eu/en/news/ema-recommends-authorisation-rasonque-metastatic-pancreatic-cancer

The European Medicines Agency's human medicines committee has recommended granting an EU marketing authorisation for Rasonque (daraxonrasib), an oral treatment for adults with metastatic pancreatic adenocarcinoma that has worsened after at least one prior therapy, the agency said in a statement. The recommendation, adopted by the Committee for Medicinal Products for Human Use (CHMP), followed a phased review that cut the assessment time to less than 150 days, compared with up to 210 active days for a standard evaluation.

Key facts

• The CHMP opinion covers Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma whose disease has progressed after at least one previous treatment.
• In a phase 3 study of 500 patients, those given Rasonque lived a median of 12.4 months, versus 6.7 months for chemotherapy; median progression-free survival was 7.2 months versus 3.6 months.
• The phased review, which began in early July 2026, reduced the assessment time to under 150 days, compared with up to 210 active days for a standard evaluation.
• The applicant is Revolution Medicines, and daraxonrasib received orphan medicinal product designation for pancreatic cancer on 20 April 2026.
• The most common side effects reported were diarrhoea, rash, stomatitis, nausea and vomiting.

Why was a faster review used?

The CHMP opinion is an intermediate step towards patient access. It will now be sent to the European Commission, which will fast-track the decision on an EU-wide marketing authorisation for Rasonque. Once a marketing authorisation is granted, decisions on price and reimbursement will be taken at the level of each member state, taking into account the medicine's potential role in that country's national health system.

The phased review was possible because Rasonque had been identified under EMA's Cancer Medicines Pathfinder project as a high-priority medicine that could address an unmet medical need. The project allows the CHMP to begin evaluating data — quality, non-clinical and clinical — in stages as they are submitted by the company, rather than waiting for a complete application. This approach shortened the assessment time while maintaining standards for quality, safety and effectiveness, EMA said. Lessons from the Rasonque review will help inform the implementation and strengthened use of phased reviews under the EU's new pharmaceutical legislation.

What does the evidence show?

Rasonque was investigated in an open-label, phase 3, multinational study involving 500 patients with metastatic pancreatic adenocarcinoma whose disease had worsened after prior systemic treatment. Of these patients, 92% had a confirmed RAS G12 mutation, which includes the most common RAS mutations associated with the disease.

The active substance, daraxonrasib, is a RAS inhibitor. RAS proteins are involved in cell growth and survival. In pancreatic adenocarcinoma, mutations in the RAS gene cause these proteins to be permanently switched on, leading to uncontrolled growth of cancer cells. Daraxonrasib works by binding to a protein called cyclophilin A to form a complex that attaches to RAS proteins, blocking their activity, killing cancer cells and slowing cancer growth.

Patients treated with Rasonque lived for a median of 12.4 months, compared with 6.7 months for those treated with chemotherapy. The median time patients lived without their disease worsening was 7.2 months with Rasonque, compared with 3.6 months with chemotherapy. The overall survival analysis was based on data collected up to 15 June 2026, and the progression-free survival analysis on data collected up to 10 February 2026.

The most common side effects reported with Rasonque were diarrhoea, rash, stomatitis (inflammation of the lining of the mouth), nausea and vomiting.

What happens next?

The European Commission will now consider the CHMP opinion and fast-track its decision on an EU-wide marketing authorisation for Rasonque. After any authorisation, pricing and reimbursement talks will take place in each member state.

EMA said that, in agreement with the CHMP, it will consider further medicines under development for phased review when the approach is feasible and expected to accelerate assessment. Such decisions will be made case by case, based on whether the medicine is likely to address an unmet medical need and is expected to be of major public health interest, particularly in terms of therapeutic innovation.

Source: European Medicines Agency