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