01 Sep Mylortarg received FDA approval
PFIZER RECEIVES FDA APPROVAL FOR MYLOTARG™ (GEMTUZUMAB OZOGAMICIN)
ONLY APPROVED ANTIBODY-DRUG CONJUGATE FOR NEWLY DIAGNOSED AND RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA
REINTRODUCTION OF MYLOTARG SUPPORTED BY CONTINUED RESEARCH BY THE AML COMMUNITY DEMONSTRATING FAVORABLE RISK:BENEFIT PROFILE
Friday, September 1, 2017 – 11:38am EDT
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration approved MYLOTARG™ (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.1 MYLOTARG is 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 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.”