AML drug Mylotarg returns to market with new FDA approval

The US Food and Drug Administration on Friday approved Mylotarg (gemtuzumab ozogamicin) for adults with newly-diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children two years and older with relapsed or refractory CD33-positive AML.

US pharma giant Pfizer’s (NYSE: PFE) Mylotargis the first therapy with an indication that includes pediatric AML. It is also the only AML therapy that targets CD33, an antigen expressed on AML cells in up to 90% of patients, the company stated.

“The FDA approval of Mylotarg fills a critical unmet need for many adults and children with AML, which can be fatal in a matter of months or even weeks if not treated and has a high relapse rate,” said Liz Barrett, global president, Pfizer Oncology. “Based on clinical data, real-world experience and support from the AML community, we are grateful Mylotarg now has the potential to help a broad range of AML patients,” she noted.