FDA Approves First RAS-Targeting Pill for Metastatic Pancreatic Cancer

On August 26, 2026, the U.S. Food and Drug Administration (FDA) granted approval to Revolution Medicines’ oral drug daraxonrasib, marketed as Rasonque, for adults with previously treated metastatic pancreatic adenocarcinoma. The approval was granted under the agency’s Breakthrough Therapy, Orphan Drug, and Priority Review designations and was processed through the Commissioner’s National Priority Voucher program, accelerating review to less than two months.

ReutersFDA Approves Rasonque (Daraxonrasib), First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer UsNews and World ReportNew York Times

Pancreatic adenocarcinoma accounts for roughly 90 % of the 67,000 new U.S. pancreatic-cancer cases diagnosed each year and carries a five-year survival rate of about 13 % (American Cancer Society). The disease’s poor prognosis stems from late detection and a lack of effective post-chemotherapy options. Mutations in the RAS gene family, especially KRAS, drive tumor growth in the majority of cases and have long been deemed “undruggable.” Rasonque is the first FDA-cleared therapy that directly inhibits multiple RAS protein subtypes, using a molecular-glue mechanism.

Revolution Medicines wins FDA approval for Rasonque, the first drug to target the genetic driver of pancreatic cancer FDA Approves Rasonque (Daraxonrasib), First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer UsNews and World ReportReuters

The approval rests on the Phase 3 RASolute 302 trial, which enrolled 500 adults with metastatic disease who had progressed after prior therapy. Participants receiving Rasonque experienced a median overall survival of 13.2 months, compared with 6.7 months for those receiving standard chemotherapy—a near-doubling of survival time. The trial reported a 60 % reduction in risk of death (hazard ratio 0.40). More than 50 % of Rasonque-treated patients were alive at one year, versus fewer than 20 % on chemotherapy. Time to disease progression roughly doubled from 3.6 months to 7.2 months. The most common adverse events included rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.

Revolution Medicines wins FDA approval for Rasonque, the first drug to target the genetic driver of pancreatic cancer

Revolution Medicines noted that the drug will be offered through insurance coverage after an expanded-access program, which had already provided free treatment to more than 2,000 patients since May. Analysts anticipate an annual price in the several-hundred-thousand-dollar range, with the majority of costs expected to be covered by insurers.

New York Times

• “We’ve never seen a benefit like this,” — Dr. Anna Berkenblit

New York Times

• “Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” — Acting FDA Commissioner Kyle

FDA Approves Rasonque (Daraxonrasib), First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer

• “This drug showed unprecedented results in an area of high unmet need,” — Angelo de Claro

FDA Approves Rasonque (Daraxonrasib), First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer

In May 2026, the FDA issued a “safe to proceed” letter allowing Revolution Medicines to initiate an expanded-access protocol, enabling patients with serious or life-threatening conditions to receive Rasonque before formal approval. The company is now testing daraxonrasib as a first-line therapy and exploring its application in other RAS-driven cancers, including lung and colorectal malignancies, positioning the drug as a potential backbone for future oncology regimens.

Revolution Medicines wins FDA approval for Rasonque, the first drug to target the genetic driver of pancreatic cancer

All sources consistently report the median survival figures (13.2 months vs. 6.7 months) and the hazard ratio (0.40). No substantive discrepancies were identified regarding efficacy outcomes or safety profile. Pricing details remain unconfirmed by Revolution Medicines, and long-term overall survival beyond the trial period has not yet been reported.

Washington Post