The Food and Drug Administration approved a pancreatic cancer drug six and a half months ahead of its deadline, and the company put the price in a filing three hours later
Thirty-nine thousand eight hundred dollars. That is what a 30-day supply of Rasonque lists at, and the number is in a securities filing rather than in the approval that made it sellable.
The Food and Drug Administration approved Rasonque, generically daraxonrasib, on Wednesday morning for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy or who cannot take multiagent chemotherapy. It is a once-daily tablet that targets multiple forms of RAS, a protein the agency describes as a driver of tumour growth in most patients with the disease. The FDA calls it a first in class targeted therapy for the most common form of pancreatic cancer.
The agency put its release out at 10.33. Revolution Medicines filed the 8-K carrying the price at 13.33.
What the trial showed
In a randomised, open-label, multicentre trial of 500 adults with previously treated metastatic pancreatic adenocarcinoma, median overall survival was 13.2 months on Rasonque against 6.7 months on standard chemotherapy. The company names the study RASolute 302 and describes the comparator as investigator's choice of cytotoxic chemotherapy. Neither document gives a hazard ratio.
Angelo de Claro, who directs the FDA's Oncology Center of Excellence, said the drug "showed unprecedented results in an area of high unmet need" and noted the approval landed 6.5 months before the user fee deadline. Acting Commissioner Kyle Diamantas framed the speed as the point, saying it is the agency's "fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible." The application carried Breakthrough Therapy and Orphan Drug designations and Priority Review, and was reviewed under the Commissioner's National Priority Voucher pilot. In May the agency had already issued a safe to proceed letter allowing an expanded access protocol, so some patients were on the drug before it was approved.
The survival difference in the trial is 6.5 months, and the margin against the user fee deadline is 6.5 months. Those are the same number by coincidence and for no other reason.
The price, and what it is not
The wholesale acquisition cost is $39,800 for a 30-day supply at the recommended daily dose, per the 8-K. Twelve such supplies come to $477,600, which is arithmetic done here from the company's own figure.
Wholesale acquisition cost is the list price. It is the number before rebates, discounts, 340B, plan design, or any patient assistance the company may run, and neither the filing nor the FDA release says anything about any of those, so nothing here should be read as what a payer or a patient will pay. What the filing does establish is that the drug is on the market now, priced now, and that the price was disclosed by the sponsor rather than by the regulator.
Scale is worth stating carefully. The FDA, citing the National Cancer Institute, puts new pancreatic cancer diagnoses in the United States at about 67,000 a year, of which roughly 90 to 95 percent are adenocarcinoma, and pancreatic adenocarcinoma at roughly 3.2 percent of all cancer diagnoses while accounting for a disproportionate share of cancer deaths. The approved indication is narrower than that population, because it requires prior systemic therapy or unsuitability for multiagent treatment, and neither document estimates how many people that leaves.
The most common side effects the agency lists are rash, diarrhoea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.
