Revolution Medicines has secured FDA approval for Rasonque, a once-daily tablet targeting RAS, a key protein driving tumour growth in most pancreatic cancer patients.
The drug, known generically as daraxonrasib, is approved to treat adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or cannot tolerate multiagent treatment.
The approval arrived 6.5 months ahead of the FDA’s user fee deadline, reflecting the agency’s urgency in addressing one of oncology’s most resistant and deadly diseases.
Pancreatic adenocarcinoma accounts for 90 to 95 percent of all pancreatic cancer cases diagnosed in the United States each year, and patients typically face a grim prognosis due to late detection and aggressive progression.
The disease carries just a 13 percent five-year survival rate, a figure that has driven demand for treatments capable of meaningfully extending patient lives beyond what chemotherapy can offer.
In a final-stage trial published in May, daraxonrasib nearly doubled median survival to 13.2 months, compared with 6.7 months for patients receiving chemotherapy, the current standard of care.
The Phase 3 RASolute 302 trial met all primary and key secondary endpoints, including improvements in overall survival, progression-free survival, and patient-reported quality of life outcomes.
Patients treated with daraxonrasib also reported significantly delayed deterioration in cancer-related pain and overall global health status compared to those receiving chemotherapy.
The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations, along with Priority Review, and the application was reviewed under the Commissioner’s National Priority Voucher pilot programme.
Acting FDA Commissioner Kyle Diamantas stated: “Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer.”
Diamantas added: “It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible.”
Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said in a statement: “This drug showed unprecedented results in an area of high unmet need.”
Andrew Ko, a medical oncologist specialising in gastrointestinal cancers at the University of California, San Francisco, described the significance of the approval in particularly strong terms.
“It will be transformative in the way we treat pancreas cancer. It’s the biggest development we’ve had in pancreas cancer in decades,” Ko said.
In May, the FDA had already issued a safe-to-proceed letter allowing an expanded access treatment protocol for Rasonque, giving patients a route to the drug before formal approval was granted.
Revolution Medicines trades on the Nasdaq under the ticker RVMD, and the approval marks a pivotal commercial milestone for the company as it prepares to bring Rasonque to market.