FDA approves landmark pancreatic cancer drug that's shown to improve survival

The US FDA on Wednesday approved Revolution Medicines' Rasonque for advanced pancreatic cancer, opening a new treatment option for patients with metastatic disease. A large trial found the once-daily pill doubled survival rates, offering fresh hope for people who have exhausted other treatments. Patients taking the first-of-a-kind pill, called daraxonrasib, lived for a median of 13.2 months compared with 6.7 months for chemotherapy recipients, studies showed.

The Food and Drug Administration (FDA) on Wednesday approved a treatment for advanced pancreatic cancer, offering new life-extending care for patients with one of the most aggressive forms of cancer. WASHINGTON (AP) — The Food and Drug Administration on Wednesday approved a groundbreaking new drug for advanced pancreatic cancer, offering U.S. patients a more effective treatment against one of the deadliest types of cancer.FDA officials gave expedited approval to the first-of-a-kind pill, called daraxonrasib, which blocks a mutated protein that fuels tumor growth in more than 90% 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.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 not a cure, it’s one more option for these patients,” said Dr.

Pashtoon Kasi of City of Hope Orange County, a California-based cancer center. “But it’s the best option we’ve ever had.”Pancreatic cancer is among the most deadly forms in large part because it is hard to detect before it starts spreading to other organs. The American Cancer Society estimates 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%.The drug garnered public attention earlier this year when former Sen. Ben Sasse, R-Neb., described on CBS' “60 Minutes” how he has had less pain while taking it. A surge in public interest led the FDA to allow “expanded access,” before the drug’s official approval, for patients who met certain criteria.FDA regulators noted on Wednesday that they approved the drug more than six months ahead of their target date."It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” the FDA's acting commissioner, Kyle Diamantas, said in a statement.Unlike with other cancers that have benefited from a variety of chemotherapy alternatives, pancreatic cancer has been harder to tackle.The new drug targets mutations in the RAS gene fami…