EMA recommends Daraxonrasib for advanced pancreatic cancer treatment

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Rasonque, containing the active ingredient Daraxonrasib, for treating adults with metastatic pancreatic adenocarcinoma. The medication is intended for patients who have already failed at least one systemic therapy.

The recommendation is based on the global Phase 3 RASolute 302 study involving 500 patients. Results showed that a daily 300 mg dose of Daraxonrasib achieved a median overall survival of 13.2 months, compared to 6.7 months for those receiving standard cytotoxic chemotherapy. This represents a 60 percent reduction in the risk of death.

Additionally, the study reported a progression-free survival of 7.2 months for Daraxonrasib versus 3.6 months for chemotherapy, and an objective response rate of 30 percent compared to 11 percent. While severe side effects occurred in 43.6 percent of patients, the treatment discontinuation rate due to adverse events was notably lower at 1.2 percent, compared to 11.2 percent in the chemotherapy group. The European Commission will make the final decision on market authorization.