In 2010, Pfizer decided to withdraw from the US market Mylotarg, its cancer drug against leukemia, which was ineffective. Withdraw was supported by the FDA. However, now the Food and Drug Administration has supported the recent approval of the drug use for the treatment of acute myelogenous leukemia (AML) after Pfizer presented new data that are the basis for its use.
On Tuesday, the FDA advisory committee agreed that the new data demonstrate a positive safety profile when using the drug Mylotarg in a combined treatment regimen in conjunction with the chemotherapeutic drugs daunorubicin and cytarabine in adults with a newly established AML.
Mylotarg received an accelerated marketing authorization from the FDA for the treatment of acute myelogenous leukemia in 2000. However, officials faced many questions: for example, why it took 10 years to receive the post-registration data, and why the regulator allowed Wyeth to start a post-marketing study in 4 years. Pfizer acquired Wyeth in 2009.
According to the regulator, Mylotarg was the first drug approved by the FDA’s expedited approval procedure, which was withdrawn from the market.