Revolution’s lifesaving pancreatic cancer drug wins speedy FDA approval

WEB DESK: Revolution Medicines’ groundbreaking pancreatic cancer drug has received speedy approval from the US Food and Drug Administration (FDA) after a large clinical trial showed it could double survival rates among patients with advanced disease, offering new hope for those battling the deadly cancer.

The once-daily pill, to be marketed as Rasonque, was approved for patients with metastatic pancreatic cancer who have received prior treatment or are unable to undergo combination chemotherapy.

The drug is designed to block multiple forms of the RAS protein, which plays a key role in driving tumour growth in many pancreatic cancers.

When Revolution announced the trial results in April for the drug, it set off a firestorm of demand. The FDA quickly granted early access to it under its compassionate use program, which allows patients with serious or life-threatening conditions to get experimental treatments outside clinical trials prior to authorization by the regulator.

The treatment has already offered some patients with early access to the drug a reprieve from the toll of chemotherapy.

Barbara Andes, 88, of Fullerton, California, who began taking it in July after a year of chemotherapy, said the pill allowed her to resume regular activities and caused far less nausea and fatigue. The approval would open access to the treatment for many more patients, she added.

“For patients and families facing metastatic pancreatic cancer, this approval represents a long-awaited and long deserved advance,” said Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute.

Revolution Medicines, based in Redwood City, California, did not have an immediate response to a Reuters request for comment on pricing and availability.

Speedy review

The drug was among the first products accepted by the Food and Drug Administration for its new expedited review process last year. The process is designed to shrink timelines to as little as one to two months, from the usual 10 to 12, for therapies addressing major US health priorities and substantial unmet medical needs.

Investors have flocked to Revolution on expectations that Rasonque could become a major new treatment option, driving the company’s stock up 166 per cent this year. Its approval was widely expected and Revolution shares were relatively flat at $211.70.

RBC Capital Markets analysts said the rapid approval, along with more than 2,000 patients already enrolled in the Expanded Access Program, could help drive an estimated $28 million in US pancreatic cancer revenue in the third quarter. Fourth-quarter sales could reach $148 million.

Longer term, the analysts estimated the drug could generate $11.5 billion in annual sales. The American Cancer Society estimates about 67,350 patients to be diagnosed with pancreatic cancer this year.

“Given the impressive data and unmet need, the market could likely support premium pricing,” RBC Capital Markets analysts said.