The Food and Drug Administration approved daraxonrasib on Wednesday as a first-of-a-kind daily pill for advanced pancreatic cancer, offering patients a targeted treatment against a mutated protein that drives tumor growth in more than 90% of cases, according to federal regulators and drugmaker Revolution Medicines. The expedited approval provides a new option for patients whose metastatic cancer has stopped responding to prior treatment.
Daraxonrasib Pricing and Clinical Trial Survival Rates
The daily pills will be sold under the brand name Rasonque, with a one-month supply priced at approximately $39,800, according to an announcement from Revolution Medicines. In a company-funded clinical trial tracking 500 patients with metastatic cancer, participants taking daraxonrasib nearly doubled their survival time compared to those receiving more chemotherapy, living for a median of 13.2 months versus 6.7 months, respectively. Dr. Céline Gounder, a CBS News medical correspondent, noted that patients typically receive a diagnosis late after the disease has already spread, making targeted interventions critical.
Targeting the Previously Undruggable RAS Protein
Daraxonrasib works by blocking a mutated protein in the RAS gene family that normally regulates cell growth, specifically addressing KRAS mutations that fuel pancreatic cancer. According to Dr. Gounder, scientists have referred to RAS as undruggable for the past 40 years because its physical structure made it difficult for medications to bind to the mutated proteins. Dr. Andrew Coveler of the Fred Hutch Cancer Center described the decision as one of the most anticipated approvals I can think of, calling the medicine a significant improvement rather than a cure.
Patient Impact and Regulatory Timeline
Former Sen. Ben Sasse of Nebraska, who received a stage-four pancreatic cancer diagnosis in December, shared in a “60 Minutes” interview that he participated in the clinical trial for daraxonrasib and experienced a 76% reduction in tumor volume over four months. The FDA approved the medication more than six months ahead of its target date. Acting FDA Commissioner Kyle Diamantas stated that delivering meaningful treatments to patients as quickly as possible remains a fundamental duty of the agency.
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