U.S. FDA Approves Rasonque for Advanced Metastatic Pancreatic Cancer

The U.S. Food and Drug Administration (FDA) has approved Revolution Medicines’ new oral drug Rasonque for the treatment of advanced pancreatic cancer, after a pivotal trial showed a doubling of patient survival rates.

Rasonque, taken once daily, is indicated for metastatic pancreatic cancer in patients who have already received prior therapy or are unsuitable for combination chemotherapy. The medication inhibits multiple forms of the RAS protein, a key driver of tumor growth in many pancreatic cancers.

The drug is now available in the United States at a list price of $39,800 for a 30‑day supply, with patient‑assistance programs offered by the manufacturer.

Following Revolution’s announcement of the trial results in April, demand surged and the FDA swiftly granted early‑access compassionate use, allowing eligible patients with life‑threatening disease to obtain the investigational treatment before formal approval.

Early‑access patients have reported relief from chemotherapy side effects.

An 88‑year‑old California resident, Barbara Andes, began taking Rasonque in July after a year of chemotherapy and said the pill allowed her to resume regular activities with far less nausea and fatigue.

“It’s going to open this door now commercially for so many, many more people who are suffering. It’s a godsend,” Andes said.

Speedy review

Rasonque benefited from the FDA’s expedited review pathway, which can compress the typical 10‑ to 12‑month review period to as little as one or two 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.

Since the announcement, investors have been bullish on Revolution, driving its stock up 166% this year. Following the approval, shares settled relatively steady at $211.70.

RBC Capital Markets analysts project that the rapid approval and enrollment of over 2,000 patients in the expanded‑access program could generate roughly $28 million in U.S. pancreatic‑cancer revenue in the third quarter, with fourth‑quarter sales potentially reaching $148 million.

Analysts forecast long‑term global annual sales of up to $11.5 billion. The American Cancer Society estimates about 67,350 new pancreatic cancer diagnoses in the United States this year.

Doctors hail breakthrough

Clinicians anticipate that Rasonque will transform the management of pancreatic cancer, historically a notoriously difficult disease 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 Dr. 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,” Dr. Shroff added, noting that patients remained on the drug longer than 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.

(FRANCE 24 with Reuters)

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