01—Abstract
Summary
Summary of the 8-K filed August 26, 2026. Cited figures are marked; the original filing is the authoritative source.
Revolution Medicines, Inc. (RVMD) reported in a Form 8-K filed August 26, 2026, under Item 8.01 (Other Events) that the U.S. Food and Drug Administration approved RASONQUE™ (daraxonrasib) for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
The approval was based on data from RASolute 302, a global, randomized Phase 3 clinical trial comparing RASONQUE with investigator's choice of cytotoxic chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma. The company stated that the once-daily oral tablets are now available in the United States for physicians to prescribe to eligible patients.
The filing states a wholesale acquisition cost of $39,800a for a 30-day supply, based on the recommended daily dose. The filing does not include efficacy results or commercial guidance beyond these points.
02—Key points
Key Highlights
- FDA approved RASONQUE™ (daraxonrasib) on August 26, 2026 for metastatic pancreatic adenocarcinoma in adults.
- Approved indication covers patients who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
- Approval was based on the global, randomized Phase 3 RASolute 302 trial, which compared RASONQUE with investigator's choice of cytotoxic chemotherapy.
- RASONQUE is a once-daily oral tablet and is now available in the United States for prescribing.
- Wholesale acquisition cost is $39,800 for a 30-day supply, based on the recommended daily dose.
03—Questions
Frequently Asked Questions
What did the FDA approve?
The FDA approved RASONQUE™ (daraxonrasib) for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
What clinical trial supported the approval?
The approval was based on data from RASolute 302, a global, randomized Phase 3 trial comparing RASONQUE with investigator's choice of cytotoxic chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma.
Is RASONQUE available now?
Yes. The filing states that once-daily oral RASONQUE tablets are now available in the United States for physicians to prescribe to eligible patients.
What is the price of RASONQUE?
The wholesale acquisition cost is $39,800 for a 30-day supply, based on the recommended daily dose.
04—Continue