The EU's CHMP has granted a positive opinion to Pfizer Inc.'s targeted anticancer Mylotarg (gemtuzumab ozogamicin) for use in acute myeloid leukemia (AML), setting the stage for an arrival in the EU market more than a decade after its first attempt. The decision was one of three taken by the committee on Pfizer drugs at its February meeting last week.
Mylotarg is set for approval for the treatment of AML in patients aged 15 years and above, with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL), in combination with daunorubicin and
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