The US Food and Drug Administration has granted rapid approval to a new pancreatic cancer drug developed by Revolution Medicines, after a major clinical trial demonstrated that the treatment doubled the survival rate for patients with advanced stages of the disease.
The once-daily pill, to be marketed under the brand name Rasonque, was cleared for the treatment of metastatic pancreatic cancer in patients who have received previous treatment or who cannot tolerate combination chemotherapy. The medication is engineered to block multiple variants of the RAS protein, which promotes tumor growth in many types of pancreatic cancer.
Revolution Medicines said the drug is already available in the US at a wholesale price of $39,800 for a 30-day supply. Eligible patients with private health insurance may pay as little as $0 through copayment assistance programs.
When Revolution announced clinical trial results in April, public interest drove high demand for early access to the therapy. The FDA granted early access through its compassionate use program, which allows individuals with severe or life-threatening conditions to receive experimental treatments outside formal clinical trials before regulatory authorization.
Early access provided several patients with relief from the side effects of traditional chemotherapy. Barbara Andes, an 88-year-old resident of Fullerton, California, who began taking the drug in July following a year of chemotherapy, said the pill allowed her to resume normal daily activities while causing significantly less nausea and fatigue. She added that official regulatory approval would open access to many more patients.
Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at the Dana-Farber Cancer Institute in Boston, said the approval represented a long-awaited and well-deserved breakthrough for patients and families facing metastatic pancreatic cancer. The American Cancer Society estimates that approximately 67,350 patients will be diagnosed with pancreatic cancer in the US this year.
Accelerated Regulatory Review
Rasonque was among the first products accepted into the FDA's new accelerated review process last year. The program was designed to compress evaluation timelines to between one and two months, down from the standard 10 to 12 months, for therapies addressing critical US health priorities and substantial unmet medical needs.
Investors flocked to Revolution Medicines on expectations that Rasonque could become a major new therapeutic option, driving the company's shares up by 166% this year. Because the regulatory decision was widely anticipated, Revolution shares remained relatively stable at $211.70 following the announcement.
Financial Projections and Market Impact
Financial analysts at RBC Capital Markets said the rapid approval, combined with more than 2,000 patients already enrolled in the Expanded Access Program, could generate an estimated $28 million in US pancreatic cancer treatment revenue during the third quarter. Sales in the fourth quarter could reach $148 million.
In the longer term, RBC analysts estimated that the medication could generate $11.5 billion in annual sales. Analysts at the firm noted that given the impressive trial data and urgent unmet medical need, the market would likely support premium pricing for the treatment.
