Health · Pharma & Biotech · 2 hrs ago
EU medicines panel recommends daraxonrasib for advanced pancreatic cancer
The EMA’s medicines committee recommended daraxonrasib for adults in the EU with pancreatic cancer that has spread and worsened after at least one treatment.
The drug, also called Rasonque, is taken as a tablet and is designed to block RAS proteins that help cancer cells grow.
Chemotherapy can have limited effect and serious side effects for these patients, leaving a need for other options.
In an international study of 500 patients, median survival was 12.4 months with daraxonrasib, compared with 6.7 months with chemotherapy.
Patients taking the drug also went a median of 7.2 months without their disease worsening, compared with 3.6 months for those given chemotherapy.
The recommendation is not final EU approval; the European Commission will decide whether to authorise the medicine across the bloc.
If it is authorised, each EU country will decide on price and reimbursement.
The European Medicines Agency’s medicines committee recommended authorising daraxonrasib for adults with metastatic pancreatic cancer who have already received at least one treatment.
The recommendation is not final approval; the European Commission will make the decision on an EU marketing authorisation.
In an international study of 500 patients, median survival was 12.4 months with daraxonrasib and 6.7 months with chemotherapy.
The treatment is an oral drug that blocks RAS proteins involved in cell growth and survival.
The committee used a phased, accelerated review, completing its assessment in less than 150 days.
- Who
- The EMA’s Committee for Medicinal Products for Human Use recommended the drug for adults with metastatic pancreatic cancer who have had at least one prior treatment.
- What
- The committee recommended marketing authorisation for daraxonrasib, also called Rasonque. The recommendation is not final EU approval.
- When
- The recommendation was reported on 15 October 2026.
- Where
- The proposed authorisation covers the European Union.
- Why
- The drug could provide a treatment option for patients whose cancer has worsened after earlier treatment, when standard chemotherapy is often of limited effectiveness and can be toxic.
This story does not have two clearly opposing sides.
The EMA committee began its phased review of the drug.
The committee issued a positive recommendation for daraxonrasib and sent it to the European Commission for a decision.
Individual member states will decide on pricing and reimbursement.
- Drug
- Daraxonrasib, marketed as Rasonque
- Eligible patients
- Adults with metastatic pancreatic cancer who have had at least one prior treatment
- Study size
- 500 patients
- Median survival
- 12.4 months with daraxonrasib; 6.7 months with chemotherapy
- Progression-free survival
- 7.2 months with daraxonrasib; 3.6 months with chemotherapy
- Review time
- Less than 150 days, compared with 210 days planned for the standard assessment
5 sources
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What people are saying
Voor deze groep patiënten was er nog geen gerichte behandeling beschikbaar. Het is daarom heel positief dat dit medicijn straks mogelijk aan die onvervulde behoefte kan voldoen.
Ik vind het ook positief dat het beoordelingscomité daar een versnelde procedure voor heeft doorlopen: net zo zorgvuldig, maar in een korter tijdsbestek, zodat patiënten hopelijk sneller van het middel gebruik kunnen maken.