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The Food and Drug Administration said it will allow some pancreatic cancer patients to receive access to a promising drug, even before it is officially approved for use.
The medication, daraxonrasib, is a 300 milligram pill taken once a day. The drug blocks a signal that causes cancer cells to grow non-stop. Drugmaker Revolution Medicine reported that in a clinical trial, metastatic pancreatic cancer patients who took the drug survived a median of 13 months, compared to about six months for similar patients who underwent chemotherapy.
Former Sen. Ben Sasse, 54, called daraxonrasib “a miracle drug” in a conversation with “60 Minutes” and said it has helped him live longer and with less pain. He was diagnosed with stage-four pancreatic cancer in December.
“I have much, much less pain than I had four months ago when I was diagnosed, and I have a massive 76% reduction in tumor volume over the last four months,” Sasse told Scott Pelley.
Daraxonrasib is being approved for use under the FDA’s expanded access program. Also called “compassionate use,” this option allows patients with serious or terminal conditions to take investigational therapies outside of a clinical trial. Patients with previously treated metastatic pancreatic ductal adenocarcinoma who have no other options will be eligible to receive daraxonrasib, the FDA said.
Revolution Medicine submitted the request to expand access to daraxonrasib on April 28, and the FDA approved the protocol on April 30. FDA commissioner Marty Makary said the timeline “reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer.”
“Having taken care of many patients with metastatic cancer, I am hopeful that today’s action will improve the lives of patients suffering from this disease,” Makary added.
The National Cancer Institute predicts that 67,530 new cases of pancreatic cancer will be diagnosed in 2026, and that 52,740 people will die from the disease during the same time. Pancreatic cancer accounts for 8.4% of cancer deaths, despite making up only 3.2% of new cancer cases. It has a five-year survival rate of about 13.7%, according to the NCI, but that can vary depending on a person’s individual prognosis and treatment.
