FDAnews Drug Daily Bulletin

FDA Ad Comm Recommends New Mylotarg Dose for Combination AML Treatment

July 13, 2017

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.

View today's stories