Revolution Medicines Wins FDA Approval for RASONQUE in Metastatic Pancreatic Cancer

Key Points

• Revolution Medicines received FDA approval for RASONQUE (daraxonrasib) for certain adults with metastatic pancreatic adenocarcinoma after at least one prior systemic therapy, or for patients not eligible for multi-agent therapy. The approval does not require a companion diagnostic or testing for a specific RAS mutation.
• Approval was based on Phase III RASolute 302 data showing a 60% reduction in the risk of death and nearly doubled median overall survival versus chemotherapy, along with improvements in progression-free survival, pain deterioration and quality of life.
• U.S. commercial sales began immediately at a wholesale acquisition cost of $39,800 per 30-day supply. The company has launched patient-support and market-access programs and is advancing additional Phase III trials in pancreatic cancer and other RAS-driven tumors.

Revolution Medicines NASDAQ: RVMD said the U.S. Food and Drug Administration has approved daraxonrasib under the brand name RASONQUE for certain adults with metastatic pancreatic adenocarcinoma.

The oral, once-daily RAS(ON) multi-selective inhibitor is approved for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-agent systemic therapy. The indication is not limited by tumor RAS mutation status, and no companion diagnostic is required, the company said.

Approval Based on Phase III Survival Data

The approval was supported by the global Phase III RASolute 302 study, which compared RASONQUE monotherapy with standard cytotoxic chemotherapy in previously treated metastatic pancreatic cancer. Alan Sandler, Revolution Medicines’ chief development officer, said the study showed a 60% reduction in the risk of death and nearly doubled median overall survival versus chemotherapy.

Sandler said RASONQUE also produced a statistically significant improvement in progression-free survival, as assessed by blinded independent central review. In addition, patients receiving RASONQUE experienced a significant delay in deterioration of patient-reported pain and overall quality-of-life measures compared with chemotherapy.

The company said it identified no new safety signals in RASolute 302 relative to earlier studies. Treatment-emergent adverse events were generally manageable through established management and dose-modification strategies, while treatment discontinuations due to adverse events were substantially less frequent than with chemotherapy, according to Sandler.

Results from RASolute 302 were presented at the 2026 ASCO Congress in May and published simultaneously in the New England Journal of Medicine, Sandler said.

Commercial Launch Begins in the U.S.

RASONQUE is commercially available in the United States beginning immediately. Anthony Mancini, chief global commercialization officer, said the medicine carries a wholesale acquisition cost of $39,800 for a 30-day supply at the recommended daily dose.

The company said its market-access, manufacturing, distribution and patient-support operations are in place for the launch. Its (ON)Path patient-services program will provide coverage navigation, financial support, adherence resources and educational materials for patients, caregivers and healthcare teams.

Eligible commercially insured patients may qualify for co-pay assistance as low as $0, Mancini said. He added that commercially insured patients already receiving daraxonrasib through the company’s expanded access program are expected to transition to commercial supply within a few months. The expanded access portal will close, though it will remain available for a limited transition period.

Revolution Medicines said its field-based market-access teams have conducted pre-approval information exchanges with payers representing more than 80% of covered lives. Mancini said the company expects payer policies to be published relatively quickly, while early access may also occur through medical exceptions.

Chief Financial Officer Jack Anders said the company expects gross-to-net discounts initially to range from 20% to 30%, depending on payer mix. He said Medicare Part D is expected to represent a significant portion of eligible patients and noted that government coverage includes mandatory discounts and rebates.

Label Flexibility and Ongoing Development

Management said the prescribing information does not establish specific criteria for determining whether a patient is a candidate for multi-agent systemic therapy. Sandler said such decisions should be made by treating physicians in consultation with patients, based on individual circumstances and the risks and benefits of available treatments.

Revolution Medicines estimates that about 55,000 patients are diagnosed annually in the U.S. with metastatic pancreatic cancer, including newly diagnosed patients and those progressing from earlier-stage disease. The company said approximately 74% historically received first-line cytotoxic chemotherapy, while fewer than half of those patients subsequently received second-line treatment.

The company has four additional global Phase III registrational programs underway in pancreatic cancer, covering first-line metastatic and resectable disease. These include programs evaluating RASONQUE alone and in combination approaches involving zoldonrasib, the company’s RAS(ON) G12D-selective covalent inhibitor. A separate Phase III trial is also underway in previously treated RAS-mutant non-small cell lung cancer.

Mark Goldsmith, chairman and chief executive officer, said the company plans to establish RASONQUE as a new treatment option for eligible U.S. patients while preparing for potential launches in Europe, Japan and other markets. The European Medicines Agency’s phased review of daraxonrasib is underway, though the medicine remains investigational outside the U.S.

About Revolution Medicines (NASDAQ:RVMD)

Revolution Medicines is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapies to treat RAS-dependent cancers and other diseases driven by the RAS/MAPK pathway. The company's research efforts target historically “undruggable” proteins, aiming to inhibit critical nodes in cell signaling that promote tumor growth and therapeutic resistance.

The lead pipeline includes RMC-4630, a SHP2 inhibitor; RMC-6291, a selective KRAS G12C inhibitor; and RMC-6236, a pan-RAS inhibitor designed to address multiple RAS mutations.

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