A potentially paradigm-shifting treatment for pancreatic cancer by Revolution Medicines’ (RevMed) named Rasonque (daraxonrasib) has been approved by the US Food and Drug Administration.
Rasonque was the headline story at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, with strong clinical results that showed the drug could almost double overall survival (OS) compared to standard chemotherapy in previously treated pancreatic cancer patients. This was a significantly positive response in a disease where few effective drugs capable of extending survival in a meaningful way have been approved in the last few years.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
RevMed’s NDA for the drug was accepted a little over a month ago, and granted approval 6.5 months before the FDA’s goal date. The application was reviewed under the Commissioners National Priority Voucher Scheme that was designed to award speedy decisions. Additionally, the review was also conducted under the Real-Time Oncology Review pilot that allows rolling submissions. The drug already had a Breakthrough Therapy and Orphan Drug designations, and has been available through an expanded access program since May.
Rasonque is an oral inhibitor of RAS, a key pathway implicated in pancreatic and lung cancer. While inhibitors like Krazati (adagrasib), which was developed by the now BMS-owned Mirati Therapeutics, and Amgen’s Lumakras (sotorasib) bind to RAS in its “off-state”, Rasonque binds the target when it’s in its “on” state. Also, both Krazati and Lumakras are limited to cancers with KRAS G12C mutations, while Rasonque is indicated for all patients with pancreatic cancer who have received at least one line of systemic therapy.
RevMed’s stock has risen by more than 170% since the start of 2026, when separate rumours of an acquisition by AbbVie and MSD raised interest in the company. However, those talks did not come to fruition. The company’s market cap is now approximately $45.27bn. Prior to the approval, Rasonque sales were expected to reach $4.3bn in 2032, as per estimates by GlobalData, the parent company of Pharmaceutical Technology.
In the Phase III Resolute-302 study (NCT06625320), which compared Rasonque to chemotherapy in previously treated pancreatic cancer patients, median OS was 13.2 months with the drug and 6.7 months with standard treatment. The objective response rate (ORR) was 30% on the Rasonque arm compared to 11% with chemotherapy.
Rasonque is a once-daily tablet taken at a 300mg dose. In the Resolute-302 study, 44% of patients experienced Grade >3 adverse events (AE), which means the drug’s safety profile will likely need management, as per GlobalData. However, less than 2% of patients discontinued the study due to AEs. The most common side effects with the drug were rash and stomatitis.
More recently, the company released positive results with its next RAS inhibitor—the G12D RAS-mutation-targeting zoldonrasib—in combination with chemotherapy as a first-line treatment for RAS G12D-mutated pancreatic cancer. In the interim analysis, 82% of patients treated with the combination had an objective response, and 61% with zoldonrasib alone.
