A pancreatic cancer drug that is still experimental is already drawing intense interest after a late-stage trial found it nearly doubled median survival for some patients.

Daraxonrasib, made by Revolution Medicines, targets KRAS, the gene mutation linked to most pancreatic cancer diagnoses. In the phase 3 randomized trial, published in the New England Journal of Medicine on May 31, patients who received the drug lived a median of 13.2 months, compared with 6.7 months for those who received chemotherapy.

“Seeing this magnitude of benefit in a randomized phase 3 study is very encouraging for all patients with advanced pancreatic cancer and is a paradigm shift in this deadly disease,” Dr. Zev Wainberg, professor of medicine and investigator at the UCLA Health Jonsson Comprehensive Cancer Center and co-first author of the study, said in a news release.

Dr. Brian Wolpin, who presented the trial’s results, said: “It is exciting to see that we may soon be able to help patients with metastatic pancreatic cancer in ways we haven’t been able to before, improving both survival and quality of life.”

The US Food and Drug Administration cleared daraxonrasib on April 30 for an early access program for some patients. The drug is still under FDA review for full approval.

Reuters reported clinics are already struggling to keep up with demand.

“The public caught wind of the FDA announcement… which has triggered a deluge of patient requests,” Dr. Daniel King, medical oncologist at the Zuckerberg Cancer Center of Northwell Health, told Reuters. “Cancer centers are all figuring out how to engage with our own institutions, opening up the protocols to provide access.”

Pancreatic cancer has one of the highest mortality rates of any cancer. According to the National Cancer Institute, only 3 percent of people survive five years after diagnosis if the cancer has spread to distant parts of the body. The American Cancer Society says about 67,000 people in the United States will be diagnosed with pancreatic cancer this year, and 53,000 will die from it.

Daraxonrasib is a once-daily tablet for people with pancreatic cancer that has metastasized, or spread to other parts of the body.

The drug works by targeting KRAS. More than 90 percent of patients diagnosed with pancreatic cancer have a mutation in that gene, Dr. Christopher Lieu, an oncologist and professor at the University of Colorado Anschutz Medical School’s Department of Medicine, previously told USA TODAY.

“The drug binds to the activating pocket of (the gene mutation) and shuts it down. It’s almost like if you have a bullhorn and you cover it up so no sound can escape,” Lieu said. “There’s a possibility that this targeted therapy for pancreatic cancer could work more effectively than chemotherapy, meaning it could be a treatment with potentially less toxicity.”

The FDA has granted Revolution Medicines permission to offer the drug through an expanded access program for some previously treated patients whose pancreatic cancer has since spread. The company can provide the medication for free to some of those patients.

Under the FDA’s expedited drug review protocol, daraxonrasib could get full approval as quickly as a month or two after a formal application is filed, compared with the typical 10 to 12 months. Reuters reported Revolution Medicines had not yet filed the application, but said in an early May call there was a “full-throttle effort” to do so.

To get the drug through expanded access, a licensed treating physician must submit a request to Revolution Medicines. An institutional review board then reviews it. Reuters reported the company said it expects to respond within two business days of receiving requests. If the company decides the drug is a good fit, the details are then submitted to the FDA. Patients who receive it must be followed by hospital monitoring boards, and serious side effects or other issues must be reported to both Revolution Medicines and the FDA.

Former Republican senator Ben Sasse told CBS’s “60 Minutes” in April that daraxonrasib is a “miracle drug” that has helped him manage pancreatic cancer that spread to his lung and liver.

“I have much, much less pain than I had four months ago when I was diagnosed, and I have a massive 76 percent reduction in tumor volume over the last four months,” Sasse said. “So maybe I’m going to crank and live a year instead of a handful of months.”

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