The EMA’s human medicines committee’s positive opinion is based on data showing the oral therapy reduced the risk of death by more than fifty percent compared to chemotherapy.
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Revolution Medicines RAS inhibitor Rasonque (daraxonrasib) in metastatic pancreatic cancer.
The once-daily tablets are authorised for patients who have received at least one prior treatment. If approved by the European Commission (EC), Rasonque would represent the first broad RAS-targeted treatment option in the EU for adults with metastatic pancreatic adenocarcinoma.
The EMA’s current recommendation is based on findings from RASolute 302 trial, which showed Rasonque enabled a 60 percent reduction in risk of death compared to chemotherapy.
The FDA approved Rasonque for this indication in August. At the time, Dr Brian Wolpin, principal investigator for the Phase III RASolute 302 trial noted: “For decades, despite RAS being the main driver and potential drug target for pancreatic cancer, physicians have largely relied on intravenous cytotoxic chemotherapy to treat this aggressive disease.”
The committee’s positive opinion follows an expedited phased review of the Rasonque data, which categorised the medicine as high-priority to address unmet need. The lessons from the review will help inform use of this tool under the EU’s new pharmaceutical legislation. It is set to facilitate more streamlined evaluation of promising medicines, enabling earlier access for patients.
“[The expedited review of Rasonque] under the EMA’s Cancer Medicines Pathfinder project highlights how innovative regulatory pathways may help bring promising medicines to patients sooner”
Dr Mark Goldsmith, Chief Executive Officer and Chairman of Revolution Medicines
Dr Mark Goldsmith, Chief Executive Officer and Chairman of Revolution Medicines, said the CHMP’s positive opinion “marks a major step toward making Rasonque available to eligible adults with metastatic pancreatic cancer in the EU.”
He added that its expedited review “under the EMA’s Cancer Medicines Pathfinder project highlights how innovative regulatory pathways may help bring promising medicines to patients sooner. We look forward to the EC’s consideration of this CHMP positive opinion as we continue to work with regulatory authorities around the world to pursue additional approvals and broaden access to Rasonque.”
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