EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended that Rasonque (daraxonrasib), an oral pancreatic cancer drug from RevMed, receive approval.
Rasonque is a RAS inhibitor that works by binding to cyclophilin A. In a phase 3 study, patients taking the drug had a median survival time of 12.4 months, compared to 6.7 months with chemotherapy. Those taking the drug also had a progression-free survival of 7.2 months, compared to 3.6 months with chemotherapy.
Earlier this year, Rasonque received FDA approval for metastatic pancreatic adenocarcinoma in patients who have already received at least one systemic therapy or who are not candidates for multiagent systemic therapy. Such patients currently have few other treatment options and a poor prognosis, a key reason why the EMA’s Cancer Medicines Pathfinder project identified Rasonque as a high-priority medication. The next step will be to send CHMP’s opinion to the European Commission to fast-track the decision on EU-wide marketing authorization.