Groundbreaking pancreatic cancer drug approved by FDA: What we know
Image of RASONQUE (daraxonrasib) (Revolution Medicines)
The Food and Drug Administration has approved a landmark new drug for advanced pancreatic cancer, one of the deadliest types of the disease.
FDA gave expedited approval on Wednesday.
New pancreatic cancer drug
Big picture view:
The drug is called daraxonrasib, a pill that blocks the mutated protein known to fuel tumor growth in more than 90% of pancreatic cancer cases. It's an approach that previously eluded drugmakers for decades.
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Patients taking the drug in clinical trials nearly doubled their survival time, with fewer severe side effects than chemotherapy. The company-funded study enrolled 500 patients whose metastatic cancer had quit responding to prior treatment.
The drug garnered public attention earlier this year when former Sen. Ben Sasse, R-Neb., said 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.
By the numbers:
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.
What they're saying:
"This is one of the most anticipated approvals I can think of," said Dr. Andrew Coveler of the Fred Hutch Cancer Center. "This medicine is not a cure but a significant improvement."
What's next:
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.
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Why is pancreatic cancer so deadly?
Dig deeper:
Pancreatic cancer is among the most lethal kinds largely because it’s hard to detect before it spreads to other parts of the body. According to the American Cancer Society, about 67,000 new cases are diagnosed each year, with more than 52,000 deaths. The five-year overall survival rate is 13%.
The new drug targets mutations in the RAS gene family that normally regulates cell growth. What are known as KRAS mutations are especially critical in fueling pancreatic cancer. But a structure that made it hard for drugs to stick to the mutated proteins meant this cancer driver was long considered "undruggable."
The Source: This report includes information from The Associated Press.