BETHESDA, Md. - Despite misgivings about the efficacy package presented by Wyeth-Ayerst Laboratories, an FDA advisory panel on Friday was persuaded to recommend approval of Celltech Group plc's Mylotarg (gemtuzumab zogamicin) for use by elderly patients with relapsed CD33 positive acute myeloid leukemia (AML).

Although Wyeth-Ayerst had asked the panel to support accelerated approval of Mylotarg for all patients with relapsed CD33 positive AML, members of the Oncologic Drugs Advisory Committee (ODAC) expressed skepticism about the data, especially about the use of historical controls instead of a randomized comparison with active therapy.