Pfizer's Mylotarg Likely To Get New Orphan, Biologics Exclusivities

08 Sep 2017

• By Michael Cipriano

Return to market for leukemia drug expected to generate another orphan drug exclusivity from new indication; Mylotarg also appears on track for 12-year biologics exclusivity after being approved as BLA, rather than an NDA as it was for its initial 2000 approval.

airport runway under the sun as background

Pfizer Inc.'s 2010 withdrawal of its acute myeloid leukemia (AML) treatment Mylotarg (gemtuzumab ozogamicin) may have been the best thing that ever happened to the drug, at least when it comes to the product's exclusivity.

Mylotarg has already made a triumphant return to the market in scoring an unexpected pediatric indication and a watered down...