A pill that doubles survival: Revolution's FDA-approved drug gives pancreatic cancer patients a fighting chance

The US Food and Drug Administration (FDA) has approved Revolution Medicines' pancreatic cancer drug Rasonque after a large clinical trial showed the treatment could double survival among patients with advanced disease.

The once-daily pill has been approved for patients with metastatic pancreatic cancer who have received prior treatment or cannot undergo combination chemotherapy. It is designed to block several forms of the RAS protein, which helps drive tumour growth in many pancreatic cancers.

Revolution said Rasonque is now available in the US at $39,800 for a 30-day supply. The company also said it would provide assistance to eligible patients.


Demand for the drug surged after Revolution released trial results in April. The FDA subsequently granted early access under its compassionate-use programme, allowing patients with serious or life-threatening conditions to receive experimental treatments outside clinical trials before regulatory approval.

Barbara Andes, 88, of Fullerton, California, who began taking the drug in July after a year of chemotherapy, said it allowed her to resume regular activities while causing 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

Rasonque was reviewed under the FDA's new expedited pathway, which is designed to reduce review timelines to as little as one to two months from the usual 10 to 12 months.

"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.

Investor expectations around Rasonque have helped drive Revolution's stock up 166% this year. The company's shares were relatively flat at $211.70 following the approval, which had been widely anticipated.

RBC Capital Markets analysts said the approval, along with more than 2,000 patients already enrolled in the Expanded Access Program, could generate an estimated $28 million in US pancreatic cancer revenue for Revolution in the third quarter. They projected fourth-quarter sales of $148 million.

The analysts estimated that Rasonque could eventually generate $11.5 billion in annual global sales. The American Cancer Society estimates that about 67,350 people will be diagnosed with pancreatic cancer in the US this year.

Doctors hail breakthrough

Doctors said targeting the RAS pathway could significantly change the treatment of pancreatic cancer, a disease that has historically been 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 the development 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.

(With inputs from Reuters)