FDA approves first targeted pill for pancreatic cancer, nearly doubling survival

The U.S. Food and Drug Administration has approved a new daily pill for the most common form of pancreatic cancer, marking a significant advance against one of the deadliest malignancies. The drug, daraxonrasib, will be marketed by Revolution Medicines under the brand name Rasonque.

The approval came through an expedited process, more than six months ahead of the agency's target date. The medication works by blocking a mutated protein in the RAS gene family, which drives tumor growth in over 90% of pancreatic cancer cases. For decades, this target was considered "undruggable" because its structure resisted conventional drug binding. The new treatment uses a molecular glue approach to attach to multiple KRAS subtypes.

In a company-funded study of 500 patients whose metastatic cancer had stopped responding to prior treatment, those taking daraxonrasib lived a median of 13.2 months, compared to 6.7 months for those receiving more chemotherapy. Patients also reported fewer severe side effects.

Pancreatic cancer is notoriously difficult to detect early, often spreading before diagnosis. The American Cancer Society projects about 67,000 new U.S. cases this year, with over 52,000 deaths expected. The five-year survival rate stands at just 13%.

The drug gained public attention earlier this year when former Senator Ben Sasse discussed his reduced pain while taking it on CBS's "60 Minutes." The resulting interest prompted the FDA to allow expanded access before formal approval.

FDA acting commissioner Kyle Diamantas said in a statement that delivering more cures and meaningful treatments to patients as quickly as possible is a fundamental duty. Doctors treating pancreatic cancer are optimistic that this approval could open the door to more options, with dozens of experimental drugs now in development. Revolution Medicines is also studying the technology for other cancers, including lung cancer.