The Food and Drug Administration (FDA)’s Oncologic Drug Advisory Committee (ODAC) voted that the results from ALFA-0701 showed a favorable risk-to-benefit profile for Mylotarg (gemtuzumab ozogamicin; Pfizer) as add-on to chemotherapy for patients with newly diagnosed CD33-positive acute myeloid leukemia (AML).
Specifically, the Biologics License Application (BLA) is proposing the administration of Mylotarg 3mg/m2 on Days 1, 4, and 7 added to chemotherapy. Also included in the BLA were studies from the original New Drug Application (NDA), data from the Phase 3 randomized, open-label ALFA-0701 study, as well as an individual patient data meta-analysis (n>3,000) from five randomized Phase 3 studies.
Mylotarg, an antibody-drug conjugate (ADC), was initially approved in 2000 for use as monotherapy in patients with CD33-positive AML who had their first relapse and were aged ≥60 years. In 2010, however, Mylotarg was withdrawn after a Phase 3 study (SWOG 20106) failed to confirm a clinical benefit and the mortality rate due to treatment-related toxicity was shown to be significantly higher in the Mylotarg arm.
Mylotarg consists of calicheamicin, a cytotoxic agent, attached to a monoclonal antibody targeting CD33. When it is absorbed into the cell, calicheamicin is released causing cell death.
The FDA will decide on the approval of the Mylotarg application by September 2017 and is not bound to the vote of the ODAC.
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