The FDA has approved a new drug for pancreatic cancer, one of the hardest forms of cancer to treat. The New York Times reports:
The Food and Drug Administration approved on Wednesday a new drug for advanced pancreatic cancer, ushering in a new era of treatment for a disease that has long been considered one of the most hopeless in medicine.
The drug, taken as two pills a day, is the first of its type and has electrified cancer specialists and patients. It is not a cure, but it is the first treatment to substantially extend the lives of patients with pancreatic cancer.
The drug, daraxonrasib, is made by Revolution Medicines and will be sold under the brand name Rasonque. It was approved for patients who have metastatic pancreatic cancer and have already tried chemotherapy. In a key clinical trial, participants who got daraxonrasib lived for a median of over 13 months, compared with less than seven months for those who got chemotherapy. Some patients who have gotten the drug through clinical trials have lived for years.
The FDA announced:
The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.
This action demonstrates the agency’s commitment to moving with urgency, reducing unnecessary delays and advancing innovative treatments that can make a meaningful difference in the lives of American patients and their families.
Rasonque, a tablet taken once daily, targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma, which arises from cells lining the ducts of the pancreas.
“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,” said Acting FDA Commissioner Kyle Diamantas, J.D. “I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality.”
The approval is for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
Approximately 90% to 95% of the 67,000 new cases of pancreatic cancer diagnosed in the United States each year are pancreatic adenocarcinoma, according to the National Cancer Institute. Despite representing roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths, owing to its typically late detection, aggressive disease course, and historically limited treatment options.
In a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy.
“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence. “The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions.”
The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations. Rasonque received Priority Review for this indication. The application was also reviewed under the Commissioner’s National Priority Voucher pilot program, which is intended to help accelerate the review of therapies that address national public health priorities.
In May, the FDA issued a “safe to proceed” letter allowing the sponsor to initiate an expanded access treatment protocol for Rasonque, enabling patient access to the investigational drug prior to approval under applicable FDA regulations.
The most common side effects of the drug are rash, diarrhea, stomatitis (inflammation of the mouth’s mucus membranes), nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
The FDA granted the approval to Revolution Medicines, Inc.
Revolution Medicines announced in a press release on the approval:
RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy
In the Phase 3 RASolute 302 trial, RASONQUE reduced the risk of death by 60% and demonstrated an unprecedented overall survival benefit compared with chemotherapy, with statistically significant and clinically meaningful improvements across all primary and key secondary endpoints
In the RASolute 302 trial, RASONQUE demonstrated manageable safety and a favorable tolerability profile compared to chemotherapy, and improved maintenance of patient-reported quality of life measures
Once-daily oral RASONQUE tablets now available by prescription in the U.S., with comprehensive patient support offered through the company’s (ON)Path™ program
Company to host webcast today, August 26, at 1:30 p.m. Eastern Time
REDWOOD CITY, Calif., Aug. 26, 2026 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a global commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved RASONQUE (daraxonrasib) once-daily oral tablets, for the treatment of adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.1 RASONQUE represents the first targeted cancer medicine to be approved from a groundbreaking new class of RAS(ON) multi-selective and mutant-selective inhibitors.
Pancreatic cancer is among the most challenging malignancies, frequently presenting with a late diagnosis, aggressive biology and limited responsiveness to conventional treatments. RAS, a key growth control switch in human cells, is the main cause of pancreatic cancer, which is characterized by excessive RAS signaling. The approval of RASONQUE is for adults with metastatic PDAC with or without an identified RAS tumor mutation and does not require use of a companion diagnostic test.
“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, RAS, which has been one of the most intractable disease targets since its discovery decades ago. The unprecedented results of the global Phase 3 trial position RASONQUE to become the new standard of care for patients with metastatic pancreatic cancer under an approved label that supports real-world clinical decision-making. This approval further validates our bold RAS(ON) inhibitor strategy that includes multi-selective and mutant-selective approaches targeting a major driver of pancreatic cancer and multiple other cancers. We continue to engage with global regulatory authorities with the goal of expanding and accelerating the reach of RASONQUE,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.
“Today’s landmark approval is the most significant advance we have seen in the fight against pancreatic cancer, a devastating disease. I believe this drug will transform how pancreatic cancer is treated, giving people the opportunity for more time with loved ones, the possibility of a better quality of life and optimism that continued research may lead to even greater advances,” said Anna Berkenblit, M.D., chief scientific and medical officer of the Pancreatic Cancer Action Network (PanCAN). “In addition, an oral pill can offer a less burdensome treatment experience than standard intravenous chemotherapy. PanCAN will continue to empower patients and caregivers with the resources and knowledge they need to advocate for the care they deserve now that RASONQUE is available for doctors to prescribe.”
“I believe daraxonrasib is well positioned to become a new standard of care for adults with metastatic pancreatic cancer who have already received at least one systemic therapy or who are not candidates for multiagent systemic therapy. For decades, despite RAS being the main driver and potential drug target for pancreatic cancer, physicians have largely relied on intravenous cytotoxic chemotherapy to treat this aggressive disease. This approval gives physicians the confidence that directly inhibiting RAS can make a striking difference for patients and provides a critically needed new approach to treating patients with metastatic pancreatic cancer,” added Brian M. Wolpin, M.D., M.P.H., director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School, and principal investigator for the RASolute 302 trial.
RASolute 302: Phase 3 Clinical Trial Results Supporting FDA Approval
The FDA approval of RASONQUE is based on data from RASolute 302, a global, randomized Phase 3 trial evaluating RASONQUE versus investigator’s choice of cytotoxic chemotherapy in patients with previously treated metastatic PDAC. The trial met all primary and key secondary endpoints in both the RAS G12 mutant population and the overall intent-to-treat (ITT) population, which included patients with or without an identified tumor RAS mutation. Results from the RASolute 302 trial were presented at the 2026 American Society of Clinical Oncology Annual Meeting with simultaneous publication in The New England Journal of Medicine.
In the ITT population, RASONQUE reduced the risk of death by 60% compared with chemotherapy, with a hazard ratio (HR) of 0.40 (95% confidence interval [CI]: 0.30–0.53; p<0.0001). The median overall survival was 13.2 months (95% CI: 10.0–NE) with RASONQUE compared to 6.7 months (95% CI: 5.8–8.0) for chemotherapy. RASONQUE also showed significant improvements in progression-free survival (PFS) with an HR of 0.49 (95% CI: 0.38–0.64; p<0.0001). The median PFS was 7.2 months (95% CI: 5.7–7.5) with RASONQUE compared to 3.6 months (95% CI: 2.9–4.2) with chemotherapy. Results were generally consistent in the RAS G12 population.
RASONQUE demonstrated manageable safety and a favorable tolerability profile. The most common (≥ 20%) adverse reactions in patients treated with RASONQUE were rash, diarrhea, stomatitis, nausea, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. Please see the Important Safety Information for RASONQUE below.
The trial also evaluated patient-reported outcomes in the ITT population, given the high symptom burden that patients with metastatic PDAC experience. Patients who received RASONQUE demonstrated a statistically significant and clinically meaningful delay in time to deterioration (TTD) for global health status and pain when compared to chemotherapy. RASONQUE prolonged the maintenance of global health status and quality of life, with a median TTD of 5.7 months versus 2.6 months with chemotherapy (HR=0.60 [95% CI: 0.46–0.79]; p<0.001). Additionally, RASONQUE delayed the worsening of clinically relevant pain, demonstrating a median TTD of 9.2 months compared to 3.8 months with chemotherapy (HR=0.51 [95% CI: 0.37–0.71]; p<0.001).
