The Food and Drug Administration announced Wednesday that it has granted fast‑track approval to a first‑of‑its‑kind oral medication for the most common form of pancreatic cancer. The drug, daraxonrasib, targets a mutated KRAS protein that drives tumor growth in more than 90% of pancreatic cancer cases.
How the drug works
Daraxonrasib acts like a molecular “glue,” binding to several KRAS subtypes and blocking the signal that fuels cancer cells. This approach overcomes a long‑standing obstacle: the KRAS protein was previously considered “undruggable” because of its shape. Revolution Medicines, based in Redwood City, California, markets the pill under the brand name Rasonque.
Clinical results
In a company‑funded, randomized study of 500 patients whose metastatic disease had stopped responding to prior therapy, those who received daraxonrasib lived a median of 13.2 months, compared with 6.7 months for patients who continued standard chemotherapy. Participants also reported fewer severe side effects, suggesting a better quality of life during treatment.
Impact on patients and families
Pancreatic cancer remains one of the nation’s most lethal cancers, largely because it is often diagnosed after it has spread. The American Cancer Society estimates roughly 67,000 new cases and more than 52,000 deaths in the United States this year, with a five‑year overall survival rate of just 13%.
Earlier this year, former Senator Ben Sasse (R‑Neb.) shared on CBS’s “60 Minutes” that the drug reduced his pain, sparking public interest and prompting the FDA to allow “expanded access” for patients meeting specific criteria before formal approval.
Regulatory timeline
FDA Acting Commissioner Kyle Diamantas said the agency approved the medication more than six months ahead of its target date, emphasizing the department’s “fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible.”
Future outlook
Oncologists are optimistic that the approval of daraxonrasib will open the door for additional targeted therapies. Revolution Medicines is already investigating the same technology for other cancers, including lung cancer, and dozens of experimental drugs are in development for pancreatic disease.
While the new pill does not cure pancreatic cancer, its ability to extend survival and reduce treatment toxicity represents a meaningful advance for patients, families, and the broader medical community.
Original reporting: Alexandria, VA News – WTOP News — read the source article.