EMA fast-tracks review of Revolutions' experimental pancreatic cancer pill
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July 7 (Reuters) - The European Medicines Agency said on Tuesday it has begun a rolling review of Revolution Medicines' RVMD.O 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.
