5 September 2017 - - New York, New York-based biopharmaceutical and healthcare products specialist Pfizer Inc. (NYSE: PFE) has received US Food and Drug Administration approval for Mylotarg (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia, and adults and children 2 years and older with relapsed or refractory CD33-positive AML, the company said.
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.
Mylotarg was originally approved in 2000. In 2010, Pfizer voluntarily withdrew it in the US after a confirmatory trial failed to show clinical benefit and there was a higher rate of fatal toxicity compared to chemotherapy.
Due to the critical unmet need for patients with AML, there remained great interest among AML clinicians to evaluate Mylotarg using different doses and different schedules. These independent investigators, with Pfizer's support, conducted clinical trials, ALFA-0701, AML-19, and MyloFrance-1, that yielded more information on the efficacy and safety of Mylotarg.
Mylotarg is an antibody-drug conjugate composed of the cytotoxic agent calicheamicin, attached to a monoclonal antibody targeting CD33, an antigen expressed on the surface of myeloblasts in up to 90 % of AML patients. When Mylotarg binds to the CD33 antigen on the cell surface it is absorbed into the cell and calicheamicin is released causing cell death.
Mylotarg originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing, clinical development and commercialization activities for this molecule.
Pfizer Oncology's focus is on identifying and translating scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines.
Pfizer discovers, develops, manufactures, and sells healthcare products worldwide. Its global portfolio includes medicines and vaccines as well as consumer health care products. The company collaborates with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world.