The Food and Drug Administration said Friday that it has granted “expanded access” to a promising pancreatic cancer drug, allowing it to be given to a wider population of patients while it remains under regulatory review.
The FDA said the action recognizes the dire need for a drug to improve survival for patients with pancreatic cancer, one of the most stubbornly lethal forms of the disease. The FDA said it received an application for expanded access from the experimental drug’s manufacturer, Revolution Medicines, on Tuesday. The agency approved it Thursday.
“Granting the request two days after receiving the expanded access application reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer,” said FDA Commissioner Marty Makary.
“Having taken care of many patients with metastatic cancer,” he said, “I am hopeful that today’s action will improve the lives of patients suffering from this disease.”
The Revolution Medicines pill, daraxonrasib, has raised hopesamong doctors, patients and advocates. In trials, it has doubled average survival time for pancreatic cancer patients who have already received conventional treatment. The expanded access program will be limited to that set of patients as well.
“Revolution Medicines is moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States,” the company said in a news release Friday. Requests for expanded access must be initiated by a licensed treating physician.
The company did not immediately respond to a question about whether it would pay for the drug during the expanded access period, or how many patients it expected will receive it. Insurance typically does not cover expanded access drugs before they have been approved.
Daraxonrasib inhibits a protein that signals cancer cells to multiply and drives tumor formation and growth. In a Phase 3 clinical trial, patients had a median survival of 13.2 months compared with 6.7 months for people receiving chemotherapy.
In terms of survival time, pancreatic cancer is the deadliest cancer. The FDA has given the drug the highest priority for approval, which could come as early as this year.
Ben Sasse, a former U.S. senator from Nebraska, is taking the drug to treat his pancreatic cancer and gave an interview to the New York Times about his experience, elevating public interest.
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