US approves use of landmark pancreatic cancer drug that’s shown to boost survival
The Food and Drug Administration approves a groundbreaking new drug for advanced pancreatic cancer, offering US patients a more effective treatment against one of the deadliest types of cancer.
FDA officials give expedited approval to the first-of-a-kind pill, called daraxonrasib, which blocks a mutated protein that fuels tumor growth in more than 90 percent of pancreatic cancer cases. It’s an approach that previously eluded drugmakers for decades. The daily pills will be sold by Revolution Medicines under the brand name Rasonque. A one-month supply would cost approximately $39,800, the company announced.
Patients taking the drug nearly doubled their survival time, with fewer severe side effects, in a study that randomly assigned them to receive the experimental treatment or more chemotherapy. The company-funded study enrolled 500 patients whose metastatic, or spreading, cancer had quit responding to prior treatment. Patients getting the new treatment lived for a median of 13.2 months compared with 6.7 months for chemotherapy recipients. Side effects included skin rash, mouth sores, diarrhea, and other digestive issues. “This is one of the most anticipated approvals I can think of,” Dr. Andrew Coveler of the Fred Hutch Cancer Center says. “This medicine is not a cure but a significant improvement.”
Pancreatic cancer is among the deadliest forms in large part because it is hard to detect before it starts spreading to other organs. The American Cancer Society estimates that about 67,000 new cases will be diagnosed in the United States this year and more than 52,000 people will die from the disease. The five-year overall survival rate is 13%.