EMA recommends new drug against pancreatic cancer

On October 15, the Committee for Medicinal Products for Human Use of the European Medicines Agency, the CHMP, recommended authorization of Rasonque, the trade name of daraxonrasib, for the treatment of adults with metastatic pancreatic adenocarcinoma who have already undergone at least one prior systemic therapy.

The recommendation is based on the results of the phase 3 study called RASolute 302, in which the drug nearly doubled patients’ median survival compared with standard chemotherapy used as the comparator. The dossier consulted does not report the size of the sample enrolled in the study nor further methodological details beyond the trial phase and the comparison with chemotherapy: information that is missing and must be stated as such, pending any more detailed data that may emerge with the full publication of the study.

The drug had already been approved by the U.S. Food and Drug Administration on August 26 for the same patient population, a precedent that probably accelerated the European evaluation, although the regulatory pathway between the two agencies remains formally independent.

The CHMP’s opinion is not equivalent to final authorization: the European Commission’s decision is still pending, which normally follows the scientific committee’s recommendations but must formalize it with its own act. Only after that step will it be up to the individual member states to establish the drug’s pricing and reimbursement conditions within their respective national health systems, a process that can take different amounts of time from country to country.

Metastatic pancreatic cancer remains one of the oncological conditions with the most limited therapeutic prospects, and it is in this context that the CHMP’s recommendation fits: an additional option for patients already treated with at least one line of systemic therapy, pending the European Commission’s final decision.