FDA Approves Revolution Medicines' Pancreatic Cancer Pill Rasonque, Doubling Survival
The U.S. FDA approved daraxonrasib (Rasonque), a once-daily pill for metastatic pancreatic cancer, on August 26, 2026. Clinical trials showed it doubled median survival to 13.2 months versus 6.7 months with chemotherapy, reducing death risk by 60%. Priced at $39,800 per 30-day supply, the drug targets previously undruggable RAS mutations. Analysts project $11.5 billion peak sales, marking a historic breakthrough for one of the deadliest cancers.
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FDA Approves First Broad RAS-Targeted Pill for Metastatic Pancreatic Cancer
The U.S. FDA approved Rasonque (daraxonrasib), a once-daily pill from Revolution Medicines, for adults with metastatic pancreatic cancer who have already received chemotherapy. This is the first broad RAS-targeted medicine cleared for this indication. In the RASolute 302 Phase 3 trial of 500 patients, the drug nearly doubled median overall survival to 13.2 months from 6.7 months on standard chemotherapy, and reduced the risk of death by 60%. The FDA cleared the drug in about 35 days via its National Priority Voucher program, far faster than the typical 10-12 month review. Revolution Medicines set the wholesale price at $39,800 for a 30-day supply. Analysts at RBC Capital Markets project peak annual sales of $11.5 billion. The approval transforms Revolution Medicines from a clinical-stage company into a commercial drugmaker.
Revolution Medicines Wins FDA Approval for Pancreatic Cancer Drug; Analysts Forecast $11.5 Billion Peak Sales
Revolution Medicines (NASDAQ:RVMD) received FDA approval for its pancreatic cancer drug daraxonrasib (branded Rasonque) on August 26, 2026, just one month after filing, under the expedited Commissioner's National Priority Voucher program. The once-daily pill targets metastatic pancreatic cancer in adults who have received prior systemic therapy or are ineligible for combination therapy. It uses a novel 'molecular glue' mechanism to block RAS proteins. Phase 3 data from April showed statistically significant improvements over chemotherapy with manageable side effects. Analysts project peak sales of $11.5 billion. The stock has surged 178% year-to-date, prompting the article to question whether it remains a buy after such gains. The approval marks a major milestone for treating a notoriously difficult cancer.
As RevMed preps for ‘historic’ pancreatic cancer launch, questions linger on the ground
The FDA has approved a new drug, Daraxonrasib, for the treatment of pancreatic cancer, a milestone described as 'historic' and 'exceptional' by researchers and media. Revolution Medicines (RevMed) is preparing for the commercial launch of the drug, which is poised to transform treatment for the deadly disease. However, questions remain regarding the drug's real-world impact, access, and integration into existing treatment protocols. The approval has been covered by major outlets including the Wall Street Journal, New York Times, Bloomberg, and CBS News, highlighting its significance as a breakthrough in a field with few therapeutic options.
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FDA approves pancreatic cancer drug that extends patients’ lives
The U.S. Food and Drug Administration (FDA) has approved a new drug, Daraxonrasib, for the treatment of pancreatic cancer. Clinical trials showed that the once-daily pill significantly extends patients' lives, with survival rates nearly doubling compared to existing treatments. This approval is considered a landmark breakthrough for one of the deadliest cancers, which has historically had very limited treatment options. The drug targets a specific genetic mutation common in pancreatic cancer cells. The approval was widely reported by major news outlets including The Washington Post, The New York Times, NPR, Fox News, and the BBC.
FDA Approves Revolution Medicines' Pancreatic Cancer Pill Rasonque, Seen as Proof of Broader RAS-Targeting Platform
The FDA approved Rasonque (revumenib), a once-daily pill by Revolution Medicines, for metastatic pancreatic adenocarcinoma in adults who have tried one prior treatment. The drug targets RAS protein mutations, long considered undruggable, and showed a median survival of 13.2 months versus 6.7 months with standard chemo, reducing death risk by 60%. Priced at $39,800 for a 30-day supply, the approval was fast-tracked. Investors and oncologists view it as a breakthrough for pancreatic cancer and a proof-of-concept for a platform targeting RAS mutations found in a quarter of all cancers. Revolution Medicines is also testing daraxonrasib in lung cancer.
FDA Approves Pancreatic Cancer Drug Rasonque That Could Double Survival Time
The U.S. Food and Drug Administration has approved daraxonrasib, a new once-daily pill for pancreatic cancer, sold under the brand name Rasonque by Revolution Medicines. The drug, which blocks RAS proteins, was shown in trials to double patient survival time compared to standard chemotherapy. Approved six months ahead of schedule, it joins a short list of treatment options for pancreatic cancer, the fourth leading cause of cancer deaths in the United States. The approval marks a significant advancement for one of the deadliest cancer types.