FDA Ad Comm Recommends New Mylotarg Dose for Combination AML Treatment

An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine.

FDA reviewers said patients treated with a lower dose of Mylotarg had less early mortality, liver toxicity, veno-occlusive disease, more rapid platelet recovery and less hemorrhage — all without apparent decreases in complete response, compared to doses two- and three-times higher.

Reviewers added it is not clear if the reduced dose would provide optimal safety and efficacy, and lamented the absence of dose-ranging studies and randomized trials of smaller doses.