Health Canada keeps reviewing daraxonrasib as its US price hits US$39,800 monthly
A once-daily pill that blocks a mutated protein driving more than 90 percent of pancreatic cancers pushed median survival to 13.2 months from 6.7 months on chemotherapy in a 500-patient trial.
The US Food and Drug Administration (FDA) approved the drug, daraxonrasib, on August 26 for adults with metastatic pancreatic ductal adenocarcinoma who have already had one systemic therapy or cannot tolerate combination chemotherapy, according to the agency's approval notice.
Revolution Medicines will sell the drug under the brand name Rasonque, pricing a one-month supply at US$39,800, the company told AP News.
Taken for a full year, that works out to roughly US$478,000, the New York Times reported.
According to AP News, the trial that supported approval was company-funded and enrolled patients whose metastatic cancer had stopped responding to prior treatment.
Fewer severe side effects were reported among those on daraxonrasib than among those on chemotherapy.
"This is not a cure, it's one more option for these patients," Pashtoon Kasi of City of Hope Orange County said, according to AP News. "But it's the best option we've ever had."
Acting FDA commissioner Kyle Diamantas said the approval came more than six months ahead of the agency's target date, calling it "our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible," per the FDA.
Common side effects include rash, diarrhea, mouth inflammation, nausea and reduced appetite, CBC News reported.
The FDA collaborated with Health Canada on the review through its Project Orbis framework, though the application "may still be under review" at Health Canada, the European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency.
Daraxonrasib has not yet received a Health Canada decision as of this writing; I have not found a source confirming a submission timeline or expected review date, so that remains a gap in the public record.
Jennifer Knox, a medical oncologist at Princess Margaret Cancer Centre in Toronto, described daraxonrasib as "probably the most exciting strategy in five decades" for pancreatic cancer and called it a game changer, Medscape reported from the ASCO 2026 meeting where trial results were presented.
For Canadian plan sponsors, a single ultra-high-cost cancer therapy of this kind would land in a category already under strain.
Specialty drugs made up 33.9 percent of total eligible private drug spend in 2025 despite covering just 2.1 percent of claimants, according to Telus Health's 2026 Drug Data Trends and National Benchmarks Report, cited by Insurance Business.
On the public side, drugs costing more than $10,000 annually accounted for over one third of total costs while reaching three percent of beneficiaries, the Patented Medicine Prices Review Board reported in its CompassRx analysis.
