FREE "MYLOTARG" (GEMTUZUMAB) MOVEMENT BUILDING MOMENTUM!

Prominent researchers from MD Anderson and from across the country/United States are calling for the FDA reconsideration of their decision to ban this drug which was used in Acute Myeloid Leukemia (AML).  We all used this drug as a first line drug particularly in  the Elderly where choices remain limited.  Particularly when the performance status was poor in a patient wanting treatment.  Mylotarg was dropped because lack of convincing evidence of survival benefit!  Researchers who worked with the drug have since fought to bring it back in some  form or shape now insisting it has a clear role in Acute Promyelocytic Leukemia (APL) where Arsenic Trioxide (Trisinox), All-Trans Retinoic Acid and Anthracyclines are kings.  Mylotarg seems to have a role in both first line and relapse settings by replacing Anthracyclines in those patients who may have or are susceptible to Cardiomyopathy that could result from use of Anthracyclines.

Calling it a "Lazarus like drug", Researchers are pointing to other medications that lost luster after post marketing studies failed to keep it alive, just to be resurrected after few years because of other new indications or new convincing evidences emerged.  I should stress that the death of Mylotarg was hard for those who used it!  I remember sitting in a review for board examination where Mylotarg, was discussed despite the fact that it was "dead" by FDA STANDARDS!  Clearly the reviewer was still emotional and could not remove this topic.

Advocates for the resurrection of MYLOTARG point to similar stories of drugs such as Omacetaxine Mepesuccinate (aka Homoharringtonine) which is back in Chronic Myeloid Leukemia (CML), Thalidomid in Multiple Myeloma, mouth ulcers and Leprosy, and Arsenic Trioxide itself in APL.

Researchers who have experience with Myelotarg, a well tolerated drug even in elderly, are calling for a "second look" by the FDA, particularly in this Era of Target therapy!

THE "FREE MYELOTARG" MOVEMENT IS SURELY GETTING MOMENTUM!