EMA recommends new drug for metastatic pancreatic cancer

The EMA’s Committee for Medicinal Products for Human Use has recommended authorisation, in the European Union, of Rasonque (daraxonrasib), an oral treatment for patients with metastatic pancreatic adenocarcinoma who have already undergone at least one previous treatment. The news currently comes from a single source; independent confirmation of the assessment details is not currently available.

The recommendation is based on a phase 3 study conducted on 500 patients, in which the drug brought median survival to 12.4 months, compared with 6.7 months recorded in the group treated with chemotherapy. This is a direct comparison between the two arms of the study, conducted at an advanced stage of clinical trials, the one preceding final authorisation. The material available does not specify further methodological details of the study, such as randomisation criteria or any conflicts of interest declared by the trial investigators.

The Committee’s assessment was completed in under 150 days, a shorter time than ordinary procedures, thanks to an accelerated assessment mechanism provided by the EMA for drugs considered of particular therapeutic relevance. This type of procedure is reserved for treatments that address a clinical need not otherwise met, as in the case of advanced-stage pancreatic cancers, for which available therapeutic options remain limited.

The Committee’s opinion represents a recommendation, not yet a final authorisation: the final decision rests with the European Commission, which normally adopts the indications of the Committee for Medicinal Products for Human Use before granting marketing authorisation across the entire territory of the Union. The drug is intended for patients with an already confirmed diagnosis of metastatic pancreatic adenocarcinoma, following the failure of at least one previous treatment. Should the European Commission grant authorisation, Rasonque would become available, subject to national reimbursement and distribution procedures, in individual Member States of the Union.