Monday 26 November 2018

News Alert: FDA approves ‘precision medicine’ drug for different cancers with the same mutation

The Food and Drug Administration normally approves drugs based on what type of cancer they treat, such as lung or skin cancer. The new drug, called Vitrakvi, is the second treatment to receive FDA clearance based on a biomarker found in an array of cancers. This "site-agnostic" approach means the approval is based on a mutation rather than on where the cancers are found. The drug, also called larotrectinib, was approved simultaneously for both adults and children. Typically, oncology drugs are considered much later for children. Last year, the agency approved an immunotherapy drug for tumors with a specific genetic signature, regardless of their locations. But that treatment already had been cleared for several cancers; Vitrakvi is the first drug to get initial site-agnostic approval.
 
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News Alert Nov 26, 6:10 PM
 
 
FDA approves 'precision medicine' drug for different cancers with the same mutation

The Food and Drug Administration normally approves drugs based on what type of cancer they treat, such as lung or skin cancer. The new drug, called Vitrakvi, is the second treatment to receive FDA clearance based on a biomarker found in an array of cancers.

This "site-agnostic" approach means the approval is based on a mutation rather than on where the cancers are found. The drug, also called larotrectinib, was approved simultaneously for both adults and children. Typically, oncology drugs are considered much later for children.

Last year, the agency approved an immunotherapy drug for tumors with a specific genetic signature, regardless of their locations. But that treatment already had been cleared for several cancers; Vitrakvi is the first drug to get initial site-agnostic approval.

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