Revolution's lifesaving pancreatic cancer drug wins speedy FDA approval

The U.S. FDA has approved Revolution Medicines' groundbreaking ​pancreatic cancer drug after it was shown to double the survival ​rate of patients with advanced disease in a large ‌trial, ​offering new hope to those with the deadly cancer. The once-daily pill, to be called Rasonque, was approved for metastatic pancreatic cancer in patients who have received prior treatment or cannot receive combination chemotherapy. The drug is designed ‌to block several forms of the RAS protein, which helps drive tumor growth in many pancreatic cancers.

Revolution said the drug is now available in the U.S. 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. 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 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 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 U.S. 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.