Mylotarg Approved for CD33 Positive AML
September 1, 2017 – The U.S. FDA has approved Mylotarg™ (gemtuzumab ozogamicin), manufactured by Pfizer, for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) that expresses the CD33 antigen. The drug is also indicated for the treatment of patients two years of age and up who have CD33 positive AML and have relapsed or no longer respond to standard treatment.
AML is a fast-progressing cancer of the blood and bone marrow, and is diagnosed in approximately 21,000 new patients each year in the United States. In approximately 90% of cases, AML produces a large amount of the CD33 antigen. Mylotarg contains an antibody that is specific for CD33 and helps it to target the cancerous cells; it also contains ozogamicin, an anti-tumor agent that is toxic to AML cells.
Recommended dosing for Mylotarg is based on body weight. When administered as an initial therapy, the drug may be used either as a monotherapy or in conjunction with chemotherapy. When used as a second-line treatment, Mylotarg is given as a monotherapy. It is available in single-dose vials, which contain 4.5mg of the medication for reconstitution and dilution prior to intravenous infusion.
Although Mylotarg was originally approved for the treatment of patients 60 years and up whose CD33 AML had relapsed following treatment with chemotherapy, it was voluntarily withdrawn from the market in October of 2010 due to safety concerns in the targeted patient group at the originally approved doses. The new indications for Mylotarg come with reduced recommended doses, and address different patient populations. However, a black box warning cautions that the drug may cause severe or fatal liver damage.
Mylotarg has already been launched.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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