July 7 (Reuters) – The European Medicines Agency said on Tuesday it has begun a rolling review of Revolution Medicines’ experimental treatment for patients with metastatic pancreatic cancer.
• The regulator said the decision was based on results from a late-stage study that compared the drug, daraxonrasib, with chemotherapy in previously treated patients with metastatic pancreatic cancer.
• Patients whose disease progresses after earlier treatment have limited therapeutic options and a poor prognosis, with life expectancy of about six months, the EMA said.
• The drug, daraxonrasib, is being studied in patients with metastatic pancreatic ductal adenocarcinoma, a form of pancreatic cancer that has spread to other parts of the body, who have already been treated with other therapies.
• Daraxonrasib was designated a high-priority medicine under the agency’s Cancer Medicines Pathfinder program, which supports treatments that could address significant unmet medical needs.
• In May, the U.S. FDA authorized the granting of early access before regulatory approval to Revolution Medicines’ pill for patients with previously treated pancreatic cancer.
• Under the rolling review process, the EMA’s Committee for Medicinal Products for Human Use will evaluate quality, safety and efficacy data as they become available, ahead of a formal marketing application.
• The agency said medicines assessed through rolling reviews are held to the same standards as those undergoing a conventional review, but the approach can shorten the overall assessment timeline by allowing regulators to review data before a complete application is submitted.
(Reporting by Siddhi Mahatole in Bengaluru)
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