FDA green lights early access to pancreatic cancer drug, daraxonrasib

The Food and Drug Administration on May 1 said it will grant some patients early access to Revolution Medicines' experimental pancreatic cancer drug daraxonrasib.

Daraxonrasib has not yet been approved by the FDA, but the company released promising late-stage clinical trial results in April for patients with pancreatic cancer that had spread to other parts of the body.

The FDA told the Redwood City, California-based company that it can begin an "expanded access treatment protocol" for some patients who had previously been treated for pancreatic cancer.

The FDA said it received the expanded access request from Revolution Medicines for daraxonrasib on April 28 and approved it on April 30.

Pancreatic cancer is among the most deadly forms of cancer. Estimates show more than 52,000 people will die from pancreatic cancer in 2026, a disease that accounts for 8% of all cancer deaths, according to the National Cancer Institute.

About 3% of people will survive five years after diagnosis if pancreatic cancer has spread to distant parts of the body, NCI statistics show.

On April 13, Revolution Medicines released clinical trial results of patients with pancreatic cancer that had spread to other parts of the body. The trial showed patients who took the daily oral medication daraxonrasib lived a median of 13.2 months, or nearly twice as long as the median 6.7 months for those who received standard chemotherapy.

After releasing those study results, the company said it would seek approval for daraxonrasib under the FDA's priority review program.

Former Sen. Ben Sasse, R-Nebraska, called daraxonrasib a "miracle drug" for helping him manage his pancreatic cancer, a diagnosis he announced in December. During an April 26 episode of "60 Minutes," Sasse said doctors initially gave him a prognosis of three to four months but said he has more time thanks to "providence, prayer, and a miracle drug."

Anna Berkenblit is chief scientific and medical officer with the Pancreatic Cancer Action Network, a pancreatic cancer patient advocacy group. In a statement, she said the study results were "truly remarkable," but said more study is needed to continue progress against the deadly disease.

"While these results represent a huge step forward in the field, they are just the beginning," Berkenblit said. "We know that resistance to treatment can develop, and research into drug combinations is needed to overcome these challenges."

Contributing: Saleen Martin