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New Drugs Approved in September

Mylotarg
Mylotarg

Mylotarg received green signal from the FDA on September 1, 2017 for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen. (CD33-positive AML).

Developed by Pfizer Inc. (PFE), Mylotarg originally received accelerated approval in May 2000 as a stand-alone treatment for older patients with CD33-positive AML who had experienced a relapse. However, Pfizer withdrew MYLOTARG in the U.S. in 2010, after a confirmatory trial failed to show clinical benefit and there was a higher rate of fatal toxicity compared to chemotherapy.

This approval includes a lower recommended dose, a different schedule in combination with chemotherapy or on its own, and a new patient population.

About 21,380 people are expected to be diagnosed with AML in the United States in 2017.

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