FDA approves new 'breakthrough' cancer drug

FDA approves new 'breakthrough' cancer drug (Photo: FDA)

(KUTV) -- What could be a "breakthrough" in treating some forms of cancer was recently approved by the Food and Drug Administration.

It's called Vitrakvi and it got accelerated approved by the FDA.

"Vitrakvi received an accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients," the FDA stated in a news release.

Vitrakvi doesn't work on all cancers, but some patients, including children, have seen "remarkable turnarounds."

But Vitraki comes at a very steep price for patients:

  • The cost for the children's syrup is $11,000 /month.
  • Oral capsules for adults is $32,000/month.
  • With insurance, most patients would pay $20.00 or less for a month's supply.

While the science behind the cancer breakthrough is complicated, Vitrakvi targets a specific gene in adult and child patients.

"This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated," the FDA stated in a news release.

"Today’s approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body," said FDA Commissioner Scott Gottlieb, M.D. "This new site-agnostic oncology therapy isn’t specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine. We now have the ability to make sure that the right patients get the right treatment at the right time. This type of drug development program, which enrolled patients with different tumors but a common gene mutation, wouldn’t have been possible a decade ago because we knew a lot less about such cancer mutations. Using our breakthrough therapy designation and accelerated approval processes, we support innovation in precision oncology drug development and the evolution of more targeted and effective treatments for cancer patients. This is especially true when it comes to pediatric cancers. We’re committed to continuing to advance a more modern framework of clinical trial designs that support more targeted innovations across disease types based on our growing understanding of the underlying biology of diseases like cancer."

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