The FDA has approved Revolution Medicines’ once-daily oral RASONQUE, or daraxonrasib, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic treatment.
RASONQUE is the first approved medicine from a new class of RAS(ON) multi-selective and mutant-selective inhibitors. The approval covers metastatic pancreatic ductal adenocarcinoma patients with or without an identified RAS tumor mutation and does not require a companion diagnostic test.
The decision was based on results from RASolute 302, a global randomized Phase 3 trial comparing RASONQUE with investigator’s choice of cytotoxic chemotherapy in previously treated metastatic pancreatic cancer. The study met all primary and key secondary endpoints in both the RAS G12-mutant population and the overall intention-to-treat population.
In the intention-to-treat population, RASONQUE reduced the risk of death by 60% versus chemotherapy, with a hazard ratio of 0.40 and a p-value below 0.0001. Median overall survival was 13.2 months with RASONQUE, compared with 6.7 months for chemotherapy.
The treatment also improved progression-free survival. Median progression-free survival was 7.2 months with RASONQUE, versus 3.6 months with chemotherapy, representing a hazard ratio of 0.49 and a p-value below 0.0001. Results were generally consistent in the RAS G12-mutant group.
RASONQUE also delayed deterioration in patient-reported global health status and pain. Median time to deterioration in global health status was 5.7 months with the treatment, compared with 2.6 months for chemotherapy. Median time to worsening of clinically relevant pain was 9.2 months, compared with 3.8 months.
The medicine is approved at a 300-milligram, once-daily oral dose and is available for U.S. physicians to prescribe.
Revolution Medicines said it has launched (ON)Path, a patient-support program offering assistance with insurance navigation, financial support and treatment education.
The company described RASONQUE as a targeted therapy designed to directly inhibit RAS, a key driver of pancreatic cancer. The most common adverse reactions, occurring in at least 20% of treated patients, were rash, diarrhea, stomatitis, nausea, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.
Revolution Medicines said it continues to engage with global regulators to expand and accelerate access to RASONQUE.
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