The FDA approved Revolution Medicines' RASONQUE (daraxonrasib) on Aug. 26 as the first broad RAS-targeted therapy for previously treated metastatic pancreatic cancer. Phase 3 data showed median overall survival of 13.2 months versus 6.7 months with chemotherapy, a 60 percent reduction in death risk. The company priced the once-daily oral drug at $39,800 per month and is advancing two additional Phase 3 trials in earlier disease settings.
Revolution Medicines won FDA approval Aug. 26 for daraxonrasib (RASONQUE), the first broad RAS-targeted pancreatic cancer therapy, cutting death risk 60 percent.
"This approval gives physicians the confidence that directly inhibiting RAS can make a striking difference for patients and provides a critically needed new approach to treating patients with metastatic pancreatic cancer," Brian M. Wolpin, MD, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute and principal investigator of the RASolute 302 trial, said.
The approval was based on the Phase 3 RASolute 302 trial, which enrolled 500 patients across 59 sites in six countries. Median overall survival reached 13.2 months with daraxonrasib versus 6.7 months with investigator's choice chemotherapy, a hazard ratio of 0.40 (95% CI, 0.30-0.53; p<0.0001), meaning a 60 percent lower risk of death. Median progression-free survival was 7.2 months versus 3.6 months, and the confirmed objective response rate was 31.6 percent versus 11.2 percent. Grade 3 or higher treatment-related adverse events occurred in 43.6 percent of daraxonrasib patients versus 57.5 percent on chemotherapy, while discontinuation from treatment-related adverse events was 1.2 percent versus 11.2 percent.
Revolution Medicines priced RASONQUE at $39,800 for a 30-day supply at the recommended 300 mg daily dose and launched a patient support program called (ON) Path. The company is running two additional Phase 3 trials — RASolute 303 in first-line metastatic disease and RASolute 304 in the adjuvant setting — that could expand the addressable market beyond the roughly 55,000 Americans diagnosed with metastatic pancreatic adenocarcinoma each year.
The FDA reviewed the application under its Commissioner's National Priority Voucher pilot program, granting approval 35 days after accepting the new drug application on July 22 and 6.5 months ahead of the user fee deadline. "This drug showed unprecedented results in an area of high unmet need," Angelo de Claro, MD, director of the FDA's Oncology Center of Excellence, said. The agency also selected the drug for Project Orbis, allowing concurrent review by international regulators. The European Medicines Agency began a phased review in July, and the European Society for Medical Oncology issued a Clinical Practice Guideline Express Update in August recommending daraxonrasib monotherapy after chemotherapy progression in patients with RAS G12-mutated tumors.
RASONQUE does not require a companion diagnostic, meaning patients with or without an identified RAS mutation can receive treatment. More than 90 percent of pancreatic ductal adenocarcinoma tumors harbor an oncogenic RAS mutation, making the pathway a near-universal target in the disease.
Shares traded relatively flat on approval day, with 22 analysts covering Revolution Medicines rating the stock Strong Buy and an average 12-month price target of $223.24, according to analyst consensus data. The muted reaction reflects questions about real-world uptake at the $39,800 monthly price point.
The approval confirms the RAS(ON) multi-selective inhibitor platform that Revolution Medicines has built around daraxonrasib and its pipeline of next-generation RAS-targeted candidates. Investors will watch early RASONQUE prescription trends and enrollment in RASolute 303 and 304, which could extend the drug's reach into first-line and adjuvant pancreatic cancer settings.
This article is for informational purposes only and does not constitute investment advice.
