The Food and Drug Administration approved Revolution Medicines' promising pancreatic cancer drug on Aug. 26 after a clinical trial showed life expectancy nearly doubled for patients with disease that had spread to other parts of the body.
The drug, called Rasonque, is a once-daily pill for people with metastatic pancreatic cancer who've received prior treatment or cannot receive combination chemotherapy. The drug is designed to block several forms of the RAS protein, which fuels tumor growth in many pancreatic cancers.
Revolution said the drug is now available at a price of $39,800 for a 30-day supply, with eligible commercially insured patients potentially paying as little as $0 with co-pay assistance, Reuters reported.
In April, Revolution released
promising late-stage clinical trial results for study participants with advanced pancreatic cancer. The trial showed patients who took the daily oral medication lived a median of 13.2 months, or nearly twice as long as the median 6.7 months for those who received standard chemotherapy.
Patients advocated for early access to the medication, and in the face of growing demand, the FDA on May 1 granted some patients early access to the then-experimental pancreatic cancer drug.
Former Sen. Ben Sasse, R-Nebraska, called the medication a "miracle drug" for helping him manage his pancreatic cancer, a diagnosis he announced in December. During an April 26 episode of "60 Minutes," Sasse said doctors initially gave him a prognosis of three to four months but said he has more time thanks to "providence, prayer, and a miracle drug."
The treatment has already offered other patients with early access to the drug a reprieve from the toll of chemotherapy, Reuters reported.
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.
Pancreatic cancer is among the most deadly forms of cancer. Estimates show more than 52,000 people will die from pancreatic cancer in 2026, a disease that accounts for 8% of all cancer deaths, according to the National Cancer Institute.
About 3% of people will survive five years after diagnosis if pancreatic cancer has spread to distant parts of the body, NCI statistics show.
FDA grants quick review
The drug was among the first products accepted by the FDA 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 U.S. 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% this year. Its approval was widely expected and Revolution shares were up 51 cents at $211.89 just before closing on Aug. 26.
Contributing: Reuters
This article originally appeared on USA TODAY: FDA approves life-extending pancreatic cancer drug Rasonque
