EU medicines panel backs targeted pancreatic cancer drug; approval still pending

European medicines advisers recommended Rasonque (daraxonrasib) on 15 October for adults with metastatic pancreatic adenocarcinoma who have received at least one previous treatment. It could offer a targeted option for patients with few alternatives, but the recommendation is not an EU licence: the European Commission must still decide whether to authorise the drug. [1]

In a 500-patient trial involving people whose cancer had worsened after earlier systemic treatment, median survival was 12.4 months with Rasonque, compared with 6.7 months with chemotherapy, according to the European Medicines Agency. Median time before the disease worsened was 7.2 months and 3.6 months, respectively. The trial was open-label, and 92% of participants had a confirmed RAS G12 mutation. The most commonly reported side effects included diarrhoea, rash, mouth inflammation, nausea and vomiting. [1]

Rasonque is a tablet that inhibits RAS proteins involved in cancer-cell growth. The Dutch medicines regulator describes it as a potential first targeted treatment for this group of patients — not the first treatment for pancreatic cancer, for which chemotherapy is already used. [1] [2]

The drug was approved in the United States in August for adults with metastatic pancreatic adenocarcinoma who had received at least one prior systemic therapy or were not candidates for multiagent systemic therapy. That decision does not authorise it in Europe. If the Commission grants an EU licence, price and reimbursement will be decided nationally; in the Netherlands, the Healthcare Institute would advise the minister on reimbursement. [3] [1] [2]