Drug Approvals

Loxo, Bayer get first FDA win with $400k rare cancer drug

Nov 29, 2018

A cutting-edge oncology drug developed by Loxo Oncology and Bayer has won approval in the U.S. 

Unlike medications that target a specific cancer, Loxo’s drug, Vitravki, is designed to treat a specific “TRK gene fusion” mutation, and was shown effective for treating a number of different cancers. The FDA approved Vitravki for adults and children with advanced solid tumors, and is one of the first drugs to get a regulatory nod for a tumor-agnostic indication. 

Vitravki is the first medication by Loxo to win regulatory approval and comes with a $32,800-per month price tag. 

The specific mutation only affects about 3,000 Americans every year, but some analysts have forecasted that sales for the drug could reach $1 billion by 2024. 

Loxo is also developing another drug that treats a different rare gene mutation called RET, which can be present in patients with lung, thyroid and other cancers. 

Read the full Reuters report.

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