FDA Opens Early Access to Pancreatic Cancer Drug That Nearly Doubled Survival Time

The FDA took just two days to authorize early access to a pancreatic cancer pill that nearly doubled survival time in a landmark trial, giving patients who can’t afford to wait for full approval a path to the drug now.

On April 30, the agency signed off on an expanded access program for daraxonrasib, an oral medication from Revolution Medicines, a Redwood City, California, biotech company. The company had submitted the request two days earlier, on April 28.

“Granting the request 2 days after receiving the expanded access application reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer,” FDA Commissioner Marty Makary said.

What the trial showed

In a Phase 3 trial called RASolute 302, patients with previously treated metastatic pancreatic cancer who took daraxonrasib lived a median of 13.2 months. Those who received standard chemotherapy lived a median of 6.7 months. The hazard ratio of 0.40 translates to a 60% reduction in the risk of death, with a p-value below 0.0001.

The results were so decisive that the trial’s independent data monitoring committee declared the first interim analysis final — no further data collection was needed to establish the primary endpoints.

“Patients with previously treated metastatic pancreatic cancer who received a pill called daraxonrasib lived approximately twice as long as patients who received standard of care intravenous chemotherapy, a truly remarkable result in this devastating disease,” the Pancreatic Cancer Action Network said.

Full data, including progression-free survival results, will be presented at the American Society of Clinical Oncology annual meeting in Chicago on May 29.

What expanded access means

The FDA’s authorization is not the same as approval. An expanded access program, sometimes called compassionate use, lets physicians request an investigational drug for patients who don’t qualify for or can’t access an ongoing clinical trial, while the formal review process continues. Revolution Medicines plans to enroll approximately 900 patients. Requests must be submitted by a U.S.-licensed physician on behalf of each eligible patient.

To qualify, patients must have confirmed metastatic pancreatic ductal adenocarcinoma, be in reasonably good functional condition, and have received at least one prior round of treatment for metastatic disease.

Revolution Medicines intends to file a New Drug Application with the FDA. The company will do so under a National Priority Voucher designation received in October 2025, a program that accelerates regulatory review for drugs addressing significant national health needs. The same program drove last month’s accelerated approval of Otarmeni, the first FDA-cleared gene therapy for genetic deafness.

Why pancreatic cancer is so hard to treat

Pancreatic cancer kills more Americans than any cancer except lung and colorectal. About 67,530 new cases are expected this year, with 52,740 projected deaths. The five-year survival rate for pancreatic ductal adenocarcinoma, the most common form, sits at about 8%. Most patients are diagnosed after the cancer has already spread, when five-year survival drops below 3%.

Current treatment in the second-line setting — the population studied in RASolute 302 — offers a median survival of roughly six to seven months on chemotherapy. The drug’s 13.2-month median doubles that benchmark.

Why the drug is different

Daraxonrasib targets a protein called RAS, which is mutated in more than 90% of pancreatic cancer cases and acts as the primary driver of tumor growth. For decades, researchers called RAS “undruggable.” Its structure offered no obvious place for small molecules to latch onto.

One class of drugs — including Amgen’s sotorasib and AstraZeneca’s adagrasib — eventually reached approval for a mutation called KRAS G12C. That variant accounts for about 1 to 2% of pancreatic cancer cases.

Daraxonrasib works differently. It first binds to a cellular chaperone protein called cyclophilin A. That two-protein complex then attaches to the active form of RAS, blocking its ability to signal downstream cancer-driving pathways and accelerating its natural shutdown. Because the mechanism doesn’t depend on a specific mutation, it reaches the full spectrum of RAS variants that dominate pancreatic cancer: G12D, G12V, G12R, and others.

The FDA granted the drug Breakthrough Therapy designation in July 2025, Orphan Drug designation in October 2025, and the National Priority Voucher the same month.

A public face of the trial

Former U.S. Senator Ben Sasse, 54, was diagnosed with stage-four pancreatic cancer in December 2025 and enrolled in a daraxonrasib clinical trial. In a recent “60 Minutes” interview, he said he had “much, much less pain” than at diagnosis and reported a 76% reduction in tumor volume over four months. “It’s a miracle drug,” he said.

What’s next

Revolution Medicines’ stock rose roughly 54% in the week after the trial results were announced on April 13. The company subsequently raised $2 billion in new capital.

A separate first-line trial, RASolute 303, is underway, testing daraxonrasib in patients who haven’t yet received chemotherapy for metastatic disease.

The full Phase 3 dataset, presented at ASCO in May, will form the foundation of the NDA filing. If approved, daraxonrasib would be the first approved targeted therapy to address the dominant class of RAS mutations in pancreatic cancer — a disease that has resisted nearly every targeted approach attempted over the past four decades.