Among its presentations at the American Society of Hematology meeting, Pfizer debuted Hedgehog Smoothen inhibitor PF-04449913, showing off encouraging Phase I monotherapy data in highly refractory patients. The drug would pair nicely with late-stage bosutinib to hit chronic myelogenous leukemia in two ways: through stem cells and through mature cells, Pfizer’s Rothenberg said.

Although Pfizer's voluntary withdrawal of its acute myeloid leukemia therapy Mylotarg is the first complete withdrawal of an accelerated approval NDA, but as in other cases where the confirmatory trial fails to substantiate the initial signs of efficacy that supported the accelerated approval, FDA is not completely closing the door on access to the drug

Commercialization of the fixed-dose combo buys lifecycle management for Forest and should support future drug development for partner Adamas, the originator of the technology behind the combination.