Sept 1 (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).
The drug was cleared to treat adults with newly diagnosed AML whose tumors express the CD33 antigen, as well as patients aged 2 years and older with CD33-positive AML who have relapsed, or did respond to initial treatment. (reut.rs/2gv6KYu)
Mylotarg originally secured accelerated approval in 2000 as a standalone treatment for older patients with CD33-positive AML who had experienced a relapse, but was voluntarily withdrawn after subsequent confirmatory studies failed to verify clinical benefit and demonstrated safety concerns, including a high number of deaths.
Friday’s approval includes a lower recommended dose, a different dosing schedule and a new patient population, the FDA said. (Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Martina D’Couto)