U.S. — The U.S. Food and Drug Administration approved daraxonrasib, sold under the brand name Rasonque, for the treatment of metastatic pancreatic ductal adenocarcinoma in adults who have received at least one prior systemic regimen or are ineligible for multiagent systemic therapy. Daraxonrasib is manufactured by Revolution Medicines.

"These results support daraxonrasib as the new standard of care for patients with previously treated metastatic pancreatic cancer. I've heard this study described as a home run. I would actually say it's a grand slam," medical oncologist Brian Wolpin said.

"RASolute 302 literally checks all of the boxes when we think about relevant and important and meaningful clinical outcomes. This is such an incredibly impactful study for our patients," medical oncologist Rachna Shroff said.

The FDA granted approval for daraxonrasib 6.5 months before the user fee deadline. Daraxonrasib was included in the FDA Commissioner's National Priority Voucher program. "This drug showed unprecedented results in an area of high unmet need. 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, Angelo de Claro, director of FDA's Oncology Center of Excellence, said."

It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible," Acting FDA Commissioner Kyle Diamantas said. The FDA accepted the New Drug Application (NDA) for daraxonrasib on July 22, 2026, for the treatment of previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). Revolution Medicines filed a Form 8-K on April 13, 2026."

The FDA allowed expanded access to daraxonrasib for patients with serious or life-threatening conditions prior to official approval. More than 2,000 patients received daraxonrasib through an expanded access program started by Revolution Medicines in May. Former U.S. Senator Ben Sasse participated in the clinical trial for daraxonrasib and publicly described his experience with the drug's side effects.

"I take it orally, but it’s a nasty drug. It causes crazy stuff like my body can’t grow skin and so I bleed all out of a whole bunch of parts of me that shouldn’t be bleeding," Sasse said. The most common treatment-related adverse event with daraxonrasib was skin rash, occurring in most patients. Grade 3 or higher treatment-related adverse events included rash in 13.7% of patients and stomatitis in 12% of patients.

Treatment-related adverse events led to discontinuation in 1.2% of patients in the daraxonrasib arm and a higher rate in the chemotherapy arm. Other side effects of daraxonrasib include diarrhea, mouth inflammation, nausea, tiredness, vomiting, abdominal pain, swelling, reduced appetite, and bleeding. "This is not a cure, it’s one more option for these patients. But it’s the best option we’ve ever had," medical oncologist Pashtoon Kasi said.

"This is life-altering. Not just for patients, as far as helping them extend their lives beyond anything we’d ever seen, but for us as physicians, to be able to have a different conversation than we’ve had for so long," oncologist Carla Kurkjian said. "It will be transformative in the way we treat pancreas cancer. It’s the biggest development we’ve had in pancreas cancer in decades. I’m so thankful for this as an advance for our patients," medical oncologist Andrew Ko said.

"It’s that big of a game changer for those of us who treat pancreatic cancer. It’s unprecedented," Shroff said. "I think this has opened doors for many other companies. Downstream I think there are going to be a lot more trials looking at this approach in other tumor types," Kasi said.

"Pancreatic cancer is the third leading cause of cancer death in the U.S. and the deadliest of all cancers. This is just the beginning of more advances to come," pharmacologist Channing Der said.

Why It Matters

Pancreatic cancer is the third leading cause of cancer deaths in the U.S. The five-year survival rate for pancreatic cancer is approximately 13%. The American Cancer Society estimates about 67,000 new cases of pancreatic cancer will be diagnosed in the United States this year and more than 52,000 people will die from the disease.

What's New

Later reporting identified that the FDA accepted the New Drug Application (NDA) for daraxonrasib on July 22, 2026, for the treatment of previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

The FDA approval was supported by the RASolute 302 Phase 3 clinical trial, which enrolled 500 patients with previously treated metastatic pancreatic adenocarcinoma.

Angelo de Claro, director of FDA's Oncology Center of Excellence, stated that 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. Medical oncologist Brian Wolpin described the study as a grand slam, while medical oncologist Rachna Shroff called it a game changer and unprecedented.

How Sources Differ

Sources differ on the characterization of previously treated metastatic pancreatic cancer outcomes. Brian Wolpin stated that the results support daraxonrasib as the new standard of care for patients with previously treated metastatic pancreatic cancer, describing the study as a home run and a grand slam.

Sources also differ on the extent to which data support daraxonrasib. Brian Wolpin asserted that the results support daraxonrasib as the new standard of care for patients with previously treated metastatic pancreatic cancer. The RASolute 302 clinical trial report provided data showing that in the RASolute 302 trial, patients treated with daraxonrasib had a median overall survival of 13.2 months, compared to 6.7 months for patients receiving standard chemotherapy.