The Food and Drug Administration announced Wednesday that it has granted expedited approval to daraxonrasib, an oral medication that targets a mutated KRAS protein found in more than 90% of pancreatic cancer cases. The approval marks the first time a pill has been authorized to treat the most common form of pancreatic cancer, a disease that claims tens of thousands of American lives each year.
How the drug works
Daraxonrasib functions as a molecular “glue,” binding to several KRAS subtypes and blocking the protein that drives tumor growth. For decades, KRAS mutations were considered “undruggable” because the protein’s structure resisted traditional drug binding. Revolution Medicines, based in Redwood City, California, says its approach overcomes that barrier, offering a new therapeutic pathway not only for pancreatic cancer but potentially for other KRAS‑driven tumors.
Clinical trial results
In a company‑funded, randomized study of 500 patients whose metastatic disease had stopped responding to prior therapies, those who received daraxonrasib lived a median of 13.2 months, compared with 6.7 months for patients who continued standard chemotherapy. The trial also reported fewer severe adverse events. Most common side effects were skin rash, mouth sores, diarrhea and other digestive issues, which were generally manageable.
Cost and access
Revolution Medicines will market the drug under the brand name Rasonque. A one‑month supply is priced at roughly $39,800. Earlier this year, former Senator Ben Sasse, R‑Neb., shared on CBS’s “60 Minutes” that the medication reduced his pain, prompting the FDA to allow expanded access for patients meeting specific criteria before the formal approval.
Impact on patients and the medical community
“This is one of the most anticipated approvals I can think of,” said Dr. Andrew Coveler of the Fred Hutch Cancer Center. “The medicine is not a cure but a significant improvement.” Experts believe the approval could open doors for additional KRAS‑targeted therapies, with many experimental drugs now in development.
Broader significance
Pancreatic cancer remains one of the deadliest cancers in the United States, with the American Cancer Society estimating about 67,000 new cases and more than 52,000 deaths this year. The five‑year overall survival rate sits at just 13%. The FDA’s decision to approve daraxonrasib more than six months ahead of its target date reflects a commitment to delivering meaningful treatments quickly, according to Acting Commissioner Kyle Diamantas.
Physicians hope the new option will provide a lifeline for patients who have exhausted other treatments and may spur further research into KRAS‑driven cancers such as certain lung and colorectal tumors.
Original reporting: NBC6 Miami — read the source article.
