FDA approves new cancer treatment
SILVER SPRING, Md. – On Monday, the FDA granted accelerated approval for the “tissue agnostic” cancer treatment, Vitrakvi.
According to the FDA, accelerated approval is granted for drugs that fill an unmet medical need and whose clinical trials prove to be effective.
In this instance, the need is for effective treatment for cancerous tumors that share a specific genetic mutation.
This marks the second time the FDA has approved a cancer treatment based on a common genetic feature across different types of tumors as opposed to tumors in similar places--such as breast or colon cancer, making it “tissue agnostic”.
Along with said mutation, the tumors that Vitrakvi is intended for are those tumors that are irresponsive to previous treatments, have no satisfactory alternative treatments and/or tumors that cannot be removed using surgery due to a high risk of causing fatal harm.
Examples of tumors that the medication has had a significant effect on include thyroid cancer, infantile fibrosarcoma and even lung cancer.
“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." Scott Gottlieb, M.D., FDA Commissioner
For the uninsured, the new drug could cost as much as $32,000 for a month’s supply and roughly $20 for those that are insured.