By Padmanabhan Ananthan
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.
Pancreatic cancer is among the deadliest of cancers, with one of the lowest 5-year survival rates of about 13%, according to the American Cancer Society.
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.
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 U.S. Food and Drug Administration last year for its new expedited review process, which is designed to cut timelines from the usual 10 to 12 months to as little as one to two months 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 stock up 166% this year. Its approval was widely expected and Revolution shares were relatively flat at $211.7.
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.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Devika Syamnath and Caroline Humer)
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