Revolution Medicines Wins FDA Approval for Rasonque in Pancreatic Cancer — First RAS Inhibitor for the Disease, 13.2-Month Median OS vs. 6.7 Months on Chemo

The FDA approved daraxonrasib (RASONQUE) on August 26, 2026 for adults with metastatic pancreatic adenocarcinoma — making it the first RAS inhibitor cleared for the disease, per the company's news release at ir.revmed.com.

The agency approved the once-daily oral tablet for patients who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. The recommended dose is 300 mg orally once daily until disease progression or unacceptable toxicity.

The approval rests on RASolute 302, a randomized Phase 3 trial of 500 adults with previously treated metastatic pancreatic adenocarcinoma. Patients on Rasonque achieved a median overall survival of 13.2 months; those on standard chemotherapy reached 6.7 months. The drug reduced the risk of death by 60% compared with chemotherapy, per the company's news release at ir.revmed.com.

The earlier approved RAS inhibitors — molecules from Amgen and Bristol Myers Squibb — block only the specific KRAS G12C mutation and target the protein in its inactive state. Rasonque inhibits the RAS GTPase family more broadly, does not require a companion diagnostic test, and is approved for patients with or without an identified RAS tumor mutation, per the FDA approval announcement.

"The FDA approval of RASONQUE is a monumental step forward for patients with pancreatic cancer and for the oncology field. For the first time, patients have an approved targeted medicine designed to directly inhibit the main cause of pancreatic cancer," said Dr. Mark Goldsmith, CEO and chairman of Revolution Medicines, in a statement reported by U.S. News & World Report.

The FDA granted Rasonque Breakthrough Therapy Designation and Orphan Drug Designation for previously treated metastatic pancreatic ductal adenocarcinoma. The agency also granted a separate Breakthrough Therapy Designation for adult patients with previously treated, locally advanced or metastatic non-small cell lung cancer carrying KRAS mutations other than G12C, following prior platinum-based chemotherapy and anti-PD-(L)1 antibody therapy, per the company's news release at ir.revmed.com.

RevMed set a list price of $39,800 for a 30-day supply. The drug is available now, with Onco360 named as a pharmacy partner as of August 26, 2026, per the company's release.

On the balance sheet, RevMed reported a cash position of $3.9 billion as of June 30, per MedCity News. Per Morningstar data as of August 22, 2026, shares outstanding stood at 214.34 million against a market cap of $47.02 billion. The stock closed at an all-time high of $221.15 on August 27, 2026, per Macrotrends.

Phase 3 trials are ongoing evaluating Rasonque as a first-line treatment in pancreatic cancer and as an adjuvant therapy following surgical resection, per the company's news release. The European Medicines Agency's Committee for Medicinal Products for Human Use has begun a rolling review of daraxonrasib, accepting data as they become available ahead of a full marketing authorization application.