The FDA Just Gave Pancreatic Cancer Patients Early Access To A Pill That Doubled Survival Time
The Food and Drug Administration has authorized early expanded access to a new pill called daraxonrasib, developed by Revolution Medicines, giving patients with advanced pancreatic cancer a chance to receive the experimental treatment while it awaits full regulatory approval, in a move the agency completed just two days after receiving the request. Pancreatic cancer is among the most lethal cancers in existence, with a five-year survival rate of only about 3 percent for the most common metastatic form, and until now new treatment options have been frustratingly scarce for patients who have already tried conventional therapies. The speed of the FDA's response was itself notable: the regulator received Revolution Medicines' expanded access application on April 28th and signed it on April 30th, and the FDA Commissioner said the two-day turnaround reflects the agency's commitment to getting promising treatments to patients with life-threatening conditions without delay. The pill works by targeting a protein called RAS, which is mutated in the majority of pancreatic cancer tumors and had for decades been considered essentially undruggable.
In a closely watched phase 3 trial called RASolute 302, daraxonrasib produced results the oncology community called unprecedented: patients taking the pill survived a median of 13.2 months compared to 6.7 months for those receiving standard chemotherapy, a 60 percent reduction in the risk of death. The drug is taken orally once a day and was generally well tolerated in the trial, with no new safety signals reported. Daraxonrasib has also received Breakthrough Therapy and Orphan Drug designations from the FDA, and the company says it intends to submit a full new drug application under the FDA's national priority program. Revolution Medicines said it is moving as quickly as possible to ensure safe and equitable access to the drug for eligible patients across the United States.
