Gemtuzumab Market Withdrawal
June 23, 2010
Pfizer is voluntarily discontinuing gemtuzumab (Mylotarg) due to lack of benefit and increased toxicities. Gemtuzumab received accelerated approval in 2000 for use as monotherapy in patients aged 60 and older with relapsed acute myeloid leukemia (AML) unable to tolerate other chemotherapy regimens.
A clinical trial in patients less than 61 years of age with AML was conducted to evaluate gemtuzumab in combination with standard chemotherapy compared to standard chemotherapy alone. The trial was stopped early due to increased fatal events during the induction phase and no increased survival in patients receiving gemtuzumab. Gemtuzumab has been linked to increased liver toxicity, including veno-occlusive disease, a condition that can be fatal. Based on this trial and other postmarketing information, Pfizer will be withdrawing gemtuzumab from the market in October, 2010.
FDA and Pfizer recommend no new patients be started on gemtuzumab. Also, FDA and Pfizer recommend healthcare providers discuss the potential risks associated with the gemtuzumab with patients who are currently on the medication.
Per communication with Pfizer customer service, customers will be able to return unused gemtuzumab for a refund to Pfizer after August 1, 2010. Customers can call Pfizer customer service at 1-800-666-7248 for more information on the process to return gemtuzumab.
Additional information may be found at the following links:
- FDA Medwatch:
- FDA News Release:
- Pfizer Press Release:
June 23, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.