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The U.S. FDA has approved Revolution Medicines\u2019\u00a0groundbreaking pancreatic cancer drug after it was shown to double the survival rate of patients with advanced disease in a large trial, offering new \u200bhope to those with the deadly cancer.<\/strong><\/p>\n The once-daily pill, to be called Rasonque, was approved for metastatic \u200cpancreatic 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.<\/p>\n Revolution said the drug is now available in the U.S. at \u200ba price of $39,800 for a 30-day supply, with eligible commercially insured patients potentially paying as little as $0 with co-pay assistance.<\/p>\n When Revolution \u200bannounced the trial results in April for the drug, it set off a firestorm of demand. \u2060The FDA quickly granted early access to it under its compassionate use program, which allows patients with serious or life-threatening conditions \u200bto get experimental treatments outside clinical trials prior to authorization by the regulator.<\/p>\n The treatment has already offered some patients with \u200bearly access to the drug a reprieve from the toll of chemotherapy.<\/p>\n 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 \u200bwould open access to the treatment for many more patients, she added.<\/p>\n \u201cFor patients and families facing metastatic pancreatic cancer, \u200bthis approval represents a long-awaited and long deserved advance,\u201d said Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at \u200cDana-Farber \u2060Cancer Institute.<\/p>\n Revolution Medicines, based in Redwood City, California, did not have an immediate response to a Reuters request for comment on pricing and availability.<\/p>\n 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, \u200bfrom the usual 10 to 12, \u200bfor therapies addressing major \u2060U.S. health priorities and substantial unmet medical needs.<\/p>\n Investors have flocked to Revolution on expectations that Rasonque could become a major new treatment option, driving the company\u2019s stock up 166% this \u200byear. Its approval was widely expected and Revolution shares were relatively flat at $211.70.<\/p>\n RBC Capital \u200bMarkets analysts said \u2060the 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.<\/p>\n Longer term, the analysts estimated the drug \u2060could generate $11.5 \u200bbillion in annual sales. The American Cancer Society estimates about 67,350 patients \u200bto be diagnosed with pancreatic cancer this year.<\/p>\n \u201cGiven the impressive data and unmet need, the market could likely support premium pricing,\u201d RBC Capital Markets analysts \u200bsaid.<\/p>\n<\/div>\nSPEEDY REVIEW<\/h2>\n