The Data Is Published

The New England Journal of Medicine released Phase 1/2 clinical trial data for daraxonrasib in May 2026. The study, conducted across 16 U.S. cancer centers, found that in patients with metastatic pancreatic cancer that had already stopped responding to chemotherapy, the drug halted tumor progression for a median of 8.5 months. Many patients stayed alive for close to a year and a half.

For context: the current standard of care for metastatic pancreatic cancer barely keeps most patients alive for 12 months after diagnosis, according to NBC News.

The Regulatory Green Light

The FDA has already moved. According to NBC News, the agency fast-tracked daraxonrasib for approval AND authorized an expanded access program — meaning Revolution Medicines, the drugmaker, can now give the drug to patients who aren't in a clinical trial.

The Phase 3 data dropped in April 2026, weeks before the NEJM publication. Revolution Medicines released early findings showing patients who received daraxonrasib plus chemotherapy had double the survival time compared to chemotherapy alone. The NEJM paper covers an earlier phase.

Who's Behind This and What the Drug Actually Does

Daraxonrasib — previously called RMC-6236 — targets mutations in the RAS gene. Specifically, it goes after KRAS, the most common mutation, which drives over 90% of pancreatic cancers, according to Memorial Sloan Kettering Cancer Center.

KRAS has been called "undruggable" for more than three decades. The mutation locks the RAS protein into a permanent "on" position, telling cells to divide without stopping. Nobody could figure out how to turn it off.

Daraxonrasib solves it differently. Instead of attacking the protein directly, it pairs with a protein called cyclophilin A inside the cell. The two act as a "molecular glue" — Dr. Brian Wolpin's phrase — that latches onto RAS and blocks it.

Dr. Wungki Park of Memorial Sloan Kettering, who led the early-phase clinical trial for pancreatic cancer, put it plainly: "For the first time, we can clinically target the dominant KRAS signals that drive most pancreatic cancers. This could be a paradigm shift in how we treat this cancer after more than three decades of relying mainly on chemotherapy."

Some patients reported symptom improvement within days of starting the drug. That does NOT happen with standard chemotherapy. Park confirmed this directly to Memorial Sloan Kettering's own reporting.

The Survival Numbers

Just 3% of patients diagnosed with metastatic pancreatic cancer are alive five years after diagnosis, according to the American Cancer Society cited by NBC News.

The disease is almost always caught after it has already spread. Chemo buys time — not much. This drug, in early data, is doubling survival time in the hardest cases.

Dr. Brian Wolpin, who directs the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute in Boston and led the new research, told NBC News: "This really feels like a watershed moment. It's going to shift how we think about treatment for pancreatic cancer overall."

Background: The KRAS Breakthrough

In 2013, Dr. Kevan Shokat of UC San Francisco was the first to discover a tiny "pocket" on the surface of the mutated K-Ras protein — an Achilles' heel nobody knew existed, according to UCSF. His lab developed drugs that could bind to it.

That work eventually led the FDA to approve sotorasib and adagrasib — the first two KRAS-targeting drugs ever cleared, both approved in recent years.

Daraxonrasib is the next generation. It doesn't just hit one KRAS mutation variant. It hits the RAS protein more broadly, which is why it works against over 90% of pancreatic cancer cases instead of a narrow slice.

What This Means If You're a Patient Right Now

The expanded access program is live. If you or someone you know has metastatic pancreatic cancer and standard treatment isn't working, you don't have to wait for full FDA approval. Talk to your oncologist about expanded access through Revolution Medicines.

Full FDA approval isn't guaranteed — Phase 3 results are preliminary and the FDA hasn't completed its review. But the agency's willingness to authorize expanded access before approval signals they're taking this data seriously.