Pancreatic cancer drug Daraxonrasib dubbed ‘miracle’
Daraxonrasib has been shown in clinical trials to nearly double survival times for people with pancreatic cancer that has metastasized.
A potentially groundbreaking pancreatic cancer drug that nearly doubled survival in a major clinical trial is now available to some patients through a special FDA program, giving new hope in the fight against one of the deadliest cancers in America.
Doctors at Intermountain Health are calling the experimental treatment, daraxonrasib, a “game changer” after trial results showed patients with advanced pancreatic cancer lived a median of 13.2 months, compared with 6.7 months for those who received chemotherapy.
The drug, which targets the KRAS gene mutations found in more than 90% of pancreatic cancers, has not yet received full FDA approval. But through the FDA’s Expanded Access Protocol, eligible patients at 10 Intermountain Health hospitals in Utah, Colorado and Montana may be able to receive the treatment while regulators continue reviewing it. Nine patients have already been approved and are awaiting their first shipments.
Why doctors are excited
In a phase 3 clinical trial of 500 patients with pancreatic cancer that had spread after earlier treatment, those who received daraxonrasib lived a median of 13.2 months, compared with 6.7 months for those who received chemotherapy. The findings were published May 31 in the New England Journal of Medicine.
“Patients with pancreatic cancer urgently need more treatment options,” Lewis said. “At this year’s American Society of Clinical Oncology conference, oncologists and scientists from around the world gave the research team a standing ovation when the results were presented. That’s how exciting this is.”
The drug is being studied as a second-line treatment, meaning it is intended for patients whose cancer has progressed after an earlier treatment. It has not been tested as an initial treatment or in patients whose cancer has not spread.
How does daraxonrasib work?
Daraxonrasib is a once-daily pill designed to target changes in a gene called KRAS, which helps control cell growth. KRAS mutations are found in more than 90% of pancreatic cancers and can cause cancer cells to grow uncontrollably.
The drug blocks those abnormal growth signals, helping stop cancer cells from growing and spreading.
Daraxonrasib is not a cure. Surgery remains the only potential cure for pancreatic cancer, but it is usually not an option once the disease has spread.
Daraxonrasib can cause side effects, including rash, diarrhea and mouth sores, KSL reported. Lewis said patients considering the treatment are “optimistic, but also realistic” about the possibility of gaining more meaningful time while living with the disease.
Why pancreatic cancer is so deadly
About 67,000 Americans are diagnosed with pancreatic cancer each year, and more than 52,000 die of the disease, according to the American Cancer Society. It is the third leading cause of cancer deaths in the U.S.
The cancer is difficult to detect because it often causes few noticeable symptoms early on. By the time it is diagnosed, it may have already spread beyond the pancreas, limiting treatment options.
That makes the survival results especially significant, Lewis said.
“I wish I could hand them a pill and say, ‘this is going to cure your pancreas cancer,’ and that’s not what this is,” he told KSL. “What it is, though, is potentially a treatment that’s better tolerated and more effective for longer than intravenous chemotherapy for the rest of your life.”
Who can get the drug?
Daraxonrasib has not yet received full FDA approval. The FDA’s Expanded Access Protocol allows certain patients with pancreatic cancer that has spread after previous treatment to receive the drug while the approval process continues.
Patients must be approved on a case-by-case basis. Intermountain Health said its 10 participating hospitals were selected because of their experience with cancer research and specialized cancer treatment.
“We are thrilled to have early access to a promising and desperately needed therapy for our patients with pancreatic cancer,” Dr. Ned Jones, an Intermountain Health oncologist in Colorado, said in a news release.
Dr. Alicia Swink, another Intermountain Health oncologist, said the treatment offers patients something pancreatic cancer has long lacked: more options.
“This is about more than a new drug,” Swink said in a statement. “It’s about giving patients more time and more options.”
Reporter Anthony Thompson can be reached at ajthompson@usatodayco.com, or on X @athompsonUSAT.