What Changed Since Our Last Report

The FDA gave the green light on April 30 for an early access program for daraxonrasib — meaning certain patients with metastatic pancreatic cancer can now get the drug before full approval, according to USA Today. Patients are accessing it now.

A second drug entered the picture weeks later.

Meet Elraglusib

On April 14, research supported by Actuate Therapeutics was published in Nature Medicine showing their drug, elraglusib, doubled one-year survival for pancreatic cancer patients compared to standard chemotherapy, according to Time.

This is a different drug from daraxonrasib. Different company, different mechanism, given by IV instead of a daily pill.

Actuate's study is a Phase II trial — earlier stage than Revolution Medicines' Phase III data — but the parallel survival doubling is notable. The company plans to continue testing in more patients, per Time.

Two separate drugs from two separate companies both doubled survival in the same timeframe.

The Demand Problem

Dr. Daniel King, medical oncologist at the Zuckerberg Cancer Center of Northwell Health, told Reuters that the FDA's early access announcement triggered what he called "a deluge of patient requests." Cancer centers across the country are scrambling to open protocols fast enough to keep up, according to USA Today.

This follows an announcement about a potential treatment for a disease that kills 53,000 Americans per year — the projection from the American Cancer Society for pancreatic cancer deaths in 2025, per USA Today. Clinics were not prepared for the volume.

The Numbers

Here's what the data shows:

• Daraxonrasib: median survival 13.2 months vs. 6.7 months on standard chemo — from Revolution Medicines' Phase III trial results released April 13, per Time
• Elraglusib: doubled one-year survival vs. standard chemo — Phase II data, Nature Medicine, April 14, per Time
• 90%+ of pancreatic cancer patients carry the KRAS gene mutation that daraxonrasib targets, according to Dr. Christopher Lieu, oncologist at the University of Colorado Anschutz Medical School, as cited by USA Today
• The five-year survival rate for pancreatic cancer remains at 13%, per the American Cancer Society, cited by NPR
• Only 3% survive five years if the cancer has already spread, per the National Cancer Institute, cited by USA Today

Revolution Medicines Is Moving Fast

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

The company has already filed — or plans to file — an FDA approval application. They also received what's called a Commissioner's National Priority Voucher, which puts them on an expedited FDA review timeline, according to Time.

Dr. Eileen O'Reilly, gastrointestinal oncologist at Memorial Sloan Kettering Cancer Center and a researcher involved in the daraxonrasib studies, told Time that the results "hopefully set the stage for building on targeted therapy as a major backbone for the treatment of pancreas cancer."

What This Means for Patients

If you or someone you know has been diagnosed with metastatic pancreatic cancer, daraxonrasib is accessible right now through the FDA's early access program — but you need to find an oncologist who can get you enrolled before the waitlists close. Call a major cancer center immediately.

Full FDA approval is still pending. Elraglusib is still in Phase II. For a disease where 53,000 Americans die every year and the survival odds have barely improved in decades, these developments represent significant progress.

The healthcare system is struggling to keep pace with demand.