Pfizer announced that it will be discontinuing commercial availability of Mylotarg (gemtuzumab ozogamicin for injection) and will be withdrawing the New Drug Application (NDA) for Mylotarg effective October 15, 2010 based on discussions with the FDA. Mylotarg was approved under the FDA’s accelerated approval regulations as a single agent for patients with CD33+ acute myeloid leukemia (AML) in first relapse who are ≥60 years of age and who are not considered candidates for other cytotoxic chemotherapy. The approval was based on overall response rate in three non-comparative studies and required submission of additional data to confirm clinical benefit. The required post-approval study (SWOG S0106) combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated AML. Additionally, among all patients evaluable for early toxicity, the fatal induction toxicity rate was significantly higher in patients given the combination of standard induction chemotherapy and Mylotarg than in those treated with chemotherapy alone.
Patients who are currently taking Mylotarg and those patients who have been prescribed Mylotarg may continue their course of therapy, in consultation with their physicians. However, Pfizer recommends that no new patients be prescribed Mylotarg. Future use of Mylotarg for new patients requires physician submission of an Investigational New Drug (IND) application to the FDA.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm.