By Padmanabhan Ananthan and Christy Santhosh
Aug 26 (Reuters) – 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 United States at $39,800 for a 30-day supply. The company added that it would make assistance available as well.
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.
“It’s going to open this door now commercially for so many, many more people who are suffering,” Andes said. “It’s a godsend.”
SPEEDY REVIEW
The drug was part of the Food and Drug Administration’s new expedited review process, designed to shrink timelines to as little as one to two months from the usual 10 to 12.
“This approval validates more than a decade of work aimed at pancreatic cancer, primarily RAS-driven disease, and one of the most difficult challenges in medicine, cancer biology, and drug discovery,” Revolution CEO Mark Goldsmith said.
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 global sales. The American Cancer Society estimates about 67,350 patients to be diagnosed with pancreatic cancer this year.
DOCTORS HAIL BREAKTHROUGH
Doctors expect Rasonque to transform how they tackle a disease that has been very difficult to treat.
“This is just the tip of the iceberg in terms of what we’re going to see in terms of targeting the RAS pathway for pancreas cancer,” said Rachna Shroff, chief of hematology and oncology at the University of Arizona Cancer Center.
“Not only did people live longer, but their quality of life improved,” Shroff said, noting that patients stayed on the drug longer than they did on chemotherapy.
Peter Hosein, associate director for clinical research at the Pancreatic Cancer Research Institute at Sylvester Comprehensive Cancer Center, described it as a paradigm shift.
“Researchers have been trying to make a breakthrough in RAS inhibition for decades and, due to unrelenting persistence, this breakthrough is finally here,” he said.
(Reporting by Padmanabhan Ananthan, Kamal Choudhury and Christy Santhosh in Bengaluru and Julie Steenhuysen in Chicago; Editing by Devika Syamnath, Caroline Humer and Joyjeet Das)
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