The Food and Drug Administration (FDA) on Wednesday approved a revolutionary new drug for advanced pancreatic cancer, offering patients in the United States a more effective treatment against one of the deadliest types of cancer.
FDA officials granted accelerated clearance to the first-of-its-kind pill drug called daraxonrasib, which blocks a mutated protein that drives tumor growth in more than 90% of pancreatic cancer cases. This is an approach that had been unattainable for pharmaceutical companies for decades.
The daily pills will be marketed by Revolution Medicines under the Rasonque brand. A one-month supply would cost approximately $39,800, the company announced.
Patients who took the drug They almost doubled their survival timewith fewer serious side effects, in a study in which they were randomly assigned to receive the experimental treatment or more chemotherapy. The study, funded by the company, involved 500 patients whose metastatic, or spread, cancer had stopped responding to previous treatments.
Patients who received the new treatment lived a median of 13.2 months, compared with 6.7 months for those who received chemotherapy. Side effects included skin rashes, mouth sores, diarrhea, and other digestive problems.
(One in every 1,000 people infected with measles “can die,” warns a doctor)
“This is one of the most anticipated authorizations I can think of,” said Dr. Andrew Coveler of Fred Hutch Cancer Center. “This medication is not a cure, but it does represent a significant improvement.”
Pancreatic cancer is among the deadliest types, largely because it is difficult to detect before it begins to spread to other organs. The American Cancer Society estimates that about 67,000 new cases will be diagnosed in the United States this year and that more than 52,000 people will die from the disease. The overall five-year survival rate is 13%.
(An expert assures that the vaccination rate against measles is below 90%)
The drug gained public attention earlier this year when former Sen. Ben Sasse, R-Neb., described on the show 60 Minutes from CBS how he had felt less pain when taking it. Increased public interest led the FDA to allow “expanded access,” prior to the drug’s official approval, for patients who met certain criteria.
FDA regulators said Wednesday they approved the drug more than six months before the scheduled date.
“It is our fundamental duty to bring more cures and meaningful treatments to patients as quickly as possible,” Acting FDA Commissioner Kyle Diamantas said in a statement.
Unlike other types of cancer for which there are a variety of chemotherapy alternatives, pancreatic cancer has been more difficult to combat.
(Vitamin D consumption is linked to cognitive improvement in the early stages of dementia)
The new drug targets mutations in the RAS gene family, which normally regulates cell growth. So-called KRAS mutations are especially critical in driving pancreatic cancer. However, a structure that made it difficult for drugs to bind to the mutated proteins meant this cancer driver was long considered “untreatable with drugs.”
Doctors who treat pancreatic cancer hope the drug could lead to more new options for other types of cancer, with dozens of experimental drugs in development.
“I think this has opened doors for a lot of other companies,” said Dr. Pashtoon Kasi of City of Hope Orange County, a California-based cancer center. “In the future, I think there will be many more rehearsals “to analyze this approach in other types of tumors.”
Revolution Medicines’ drug uses what is essentially molecular glue to bind to multiple KRAS subtypes. The Redwood City, California-based pharmaceutical company is studying its technology for several other forms of cancer, including lung cancer.
