06.22.10
Following discussions with the FDA, Pfizer will discontinue commercial availability of Mylotarg (gemtuzumab ozogamicin for Injection) for the treatment of relapsed acute myeloid leukemia (AML). Pfizer will also withdraw its NDA for Mylotarg effective October 15, 2010.
Mylotarg was granted approval under the FDA's accelerated approval regulations based on overall response rate in three studies, with the 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. Also, among all patients evaluable for early toxicity, the fatal induction toxicity rate was significantly higher in the combination arm than those treated with chemotherapy alone. As a result, Pfizer will withdraw the NDA for Mylotarg in AML.
"We are disappointed that the study did not confirm the clinical benefit of Mylotarg. Our primary concern is for patients who suffer from AML, which remains a very serious and difficult-to-treat disease with limited treatment options. We advise patients to contact their physicians for further information," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer Oncology Business Unit.
Mylotarg was granted approval under the FDA's accelerated approval regulations based on overall response rate in three studies, with the 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. Also, among all patients evaluable for early toxicity, the fatal induction toxicity rate was significantly higher in the combination arm than those treated with chemotherapy alone. As a result, Pfizer will withdraw the NDA for Mylotarg in AML.
"We are disappointed that the study did not confirm the clinical benefit of Mylotarg. Our primary concern is for patients who suffer from AML, which remains a very serious and difficult-to-treat disease with limited treatment options. We advise patients to contact their physicians for further information," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer Oncology Business Unit.