Hope At ASH For Failed Pfizer Leukemia Drug Mylotarg
This article was originally published in The Pink Sheet Daily
Pfizer is talking about “a path forward” for Mylotarg, the leukemia therapy it pulled off the U.S. market in 2010 for lack of both efficacy and safety, after independent French researchers tried it successfully in a different population using a different regimen from the failed confirmatory trial that sunk the antibody-drug conjugate.
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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
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