As FDA panel looks on favorably, Pfizer hopes it will be second time lucky for Mylotarg

12 July 2017

The Oncologic Drug Advisory Committee (ODAC) of the US Food and Drug Administration has provided a positive opinion on Mylotarg (gemtuzumab ozogamicin).

The advisory panel determined that, based on data from the pivotal ALFA-0701 study, the drug candidate has a favorable risk/benefit profile as an adjunctive therapy for certain newly-diagnosed acute myeloid leukemia (AML) patients.

The drug is an antibody-drug conjugate under development by New York-based Pfizer (NYSE: PFE), comprised of a cytotoxic agent attached to a monoclonal antibody.

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