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Daraxonrasib Presented at ASCO, FDA Fast-Tracks Review — And a Second Drug Just Doubled Survival Too

Daraxonrasib Presented at ASCO, FDA Fast-Tracks Review — And a Second Drug Just Doubled Survival Too
Revolution Medicines formally presented its Phase 3 daraxonrasib data at the American Society for Clinical Oncology meeting in Chicago on May 31, 2026, and the FDA is now expediting its review. What mainstream coverage is mostly burying: a completely separate company, Actuate Therapeutics, published its own pancreatic cancer drug in Nature Medicine the same week — and it also doubled survival.

The ASCO Presentation Is Done. Now What?

The Phase 3 data for daraxonrasib has been formally presented to the medical world. Dr. Brian Wolpin of the Dana-Farber Cancer Institute stood at the American Society for Clinical Oncology meeting in Chicago on May 31 and laid out the numbers: 13.2 months median survival on daraxonrasib versus 6.7 months on chemotherapy, in 500 patients with metastatic pancreatic cancer that had already stopped responding to prior treatment.

According to CNBC, the FDA is now moving to expedite its review of daraxonrasib. Revolution Medicines is the maker, and they funded the Phase 3 trial. According to TIME, Revolution Medicines was also the first cancer company to receive a Commissioner's National Priority Voucher specifically for a cancer drug — meaning the FDA has committed to a faster-than-standard decision timeline.

Dr. Mark Goldsmith, CEO of Revolution Medicines, told TIME: "These are dramatic results, with practice-changing outcomes."

Dr. Wolpin told the ASCO audience the drug should become "a new standard of care" for previously treated metastatic pancreatic cancer.

What Mainstream Coverage Is Missing: A Second Drug

On April 14, TIME reported that a completely separate company — Actuate Therapeutics — published research in Nature Medicine showing its drug, elraglusib, also doubled one-year survival for pancreatic cancer patients compared to standard chemotherapy. That research dropped the day after Revolution Medicines' daraxonrasib results.

Elraglusib is administered by IV, not a daily pill. It's a Phase 2 trial, not Phase 3 — earlier stage, fewer patients, not yet at the bar for FDA approval. Actuate plans to continue testing.

Two drugs, from two different companies, each doubling survival, within the same two-week window. NPR, AP, and CNBC are all focused almost entirely on daraxonrasib. The second drug is getting almost zero play in the major outlets.

Daraxonrasib targets a KRAS gene mutation present in more than 90% of pancreatic cancer cases, according to NPR. Elraglusib targets a different mechanism. Two different pathways. Both showing results.

The FDA Expedited Review: What It Actually Means

The Commissioner's National Priority Voucher that Revolution Medicines holds is a real accelerant. According to TIME, it guarantees the FDA will review and issue a decision on an expedited timeline. This differs from approval — but it means patients won't be waiting years in the standard queue.

The FDA is also separately granting expanded access to daraxonrasib, allowing some patients outside the trial to access the drug before formal approval. For a disease where median survival after second-line treatment used to be 6.7 months, speed of review matters.

The Real-World Numbers Behind the Hope

About 70,000 Americans are diagnosed with pancreatic cancer annually, according to NPR. About 80% of them are caught at a late stage. The five-year survival rate sits at a dismal 13%, per the American Cancer Society.

By comparison, breast cancer's five-year survival rate exceeds 90%. Prostate cancer, similarly. Pancreatic cancer has been the outlier — lethal, hard to detect early, resistant to the immunotherapy revolution that transformed other cancers.

Vicky Stinson, a 65-year-old retired landscape architect from Flagstaff, Arizona, was told she had "months — not years" after her Stage 3 diagnosis in 2024. Two years later, she participated in daraxonrasib treatment and is still going, according to NPR's May 12 report.

What Doctors Actually Said at ASCO

Dr. Rachna Shroff of the University of Arizona Cancer Center, who was NOT involved in the research, told the ASCO meeting: "Having treated pancreatic cancer for 16 years, I actually started crying" when she first saw the results.

Dr. Zev Wainberg of UCLA, who helped lead the study, told NPR the survival gap may actually widen — because many patients were still on the drug when the data was cut. The full picture hasn't landed yet.

Dr. Eileen O'Reilly of Memorial Sloan Kettering Cancer Center, who was involved with the daraxonrasib studies, told TIME the results "hopefully set the stage for building on targeted therapy as a major backbone for the treatment of pancreas cancer."

Side Effects

According to CNBC, the two side effects most likely to force patients off the drug are severe rash and mouth sores. Patients should know what they're signing up for, and that conversation belongs between patients and their oncologists.

What's Next

The ASCO presentation is complete. The FDA is moving fast. A second drug from a second company is also showing doubled survival, and it's barely getting coverage. Revolution Medicines needs FDA approval — that hasn't happened yet. But for a disease that has resisted every major treatment advance for decades, the pipeline has never looked like this.

70,000 Americans will be diagnosed with pancreatic cancer this year. Most of them will be told it's Stage 3 or 4. For the first time, the people delivering that news have something new to offer.

Sources

center-left NPR Experimental pill promises new hope for deadly pancreatic cancer
center-left npr She's trying to outrun pancreatic cancer. Breakthrough treatments give her hope
center-left cnbc Experimental pill promises new hope for deadly pancreatic cancer
left AP News Experimental pill promises new hope for deadly pancreatic cancer
unknown time Two New Drugs Offer Hope for Pancreatic Cancer