FDA approves Pfizer’s leukemia drug
(Reuters) – The U.S. Food and Drug Administration (FDA) on Friday approved Pfizer Inc’s drug, Mylotarg, for certain patients with acute myeloid leukemia (AML).
Reporting from Akankshita Mukhopadhyay in Bengaluru; Editing by Martina D’Couto
Friday’s approval includes a recommended dose, a different dosing schedule along with a patient population, the FDA said.
The drug has been cleared to treat patients aged 2 years and older with CD33-positive AML who have relapsed, as well as adults with newly diagnosed AML whose tumors express the antigen, or did respond to treatment.
Mylotarg originally secured accelerated approval as a treatment for older patients with CD33-positive AML who had experienced a relapse, but was voluntarily withdrawn after confirmatory studies demonstrated security concerns and failed to verify clinical benefit, including a number of deaths.