Europe backs a pill that doubles survival in advanced pancreatic cancer
The European Medicines Agency's drugs committee has recommended approving daraxonrasib. In the RASolute 302 trial of 500 patients, median survival rose from 6.7 to 13.2 months compared with chemotherapy.
A daily pill has achieved something rare in one of the hardest cancers to treat. The European Medicines Agency’s human medicines committee (CHMP) has recommended approving daraxonrasib (brand name Rasonque, from Revolution Medicines) for adults with metastatic pancreatic cancer who have already had at least one treatment.
The numbers
The recommendation rests on the RASolute 302 trial, in which 500 patients received either the drug or chemotherapy chosen by their doctor:
- Median survival: 13.2 months with daraxonrasib versus 6.7 with chemotherapy.
- Time before the disease progressed: 7.2 months versus 3.6.
- Tumours shrinking: in 31.6% of patients, versus 11.2%.
What happens next
The CHMP opinion is the step before approval: the European Commission now has to grant the final marketing authorisation for the EU. Each country then decides how and when to fund it. It is already approved in the United States.
Why it matters
Advanced pancreatic cancer has very few options once the first treatment stops working. Doubling median survival is not a cure, but it is time. And the drug targets RAS mutations, found in the vast majority of these tumours and long considered almost impossible to drug.
