CHMP recommends Mylotarg for previously untreated, de novo, CD33-positive AML and Bosulif for chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.- Pfizer.

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions recommending that Mylotarg (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine has been granted a positive opinion for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL).

Bosulif (bosutinib) has been granted a positive opinion for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The CHMP�s opinions for both medicines will now be reviewed separately by the European Commission (EC).

The Marketing Authorization Application (MAA) for Mylotarg was based on data from an investigator-led, phase III, randomized, open-label study (ALFA-0701) in previously untreated, de novo patients. BOSULIF currently has conditional marketing authorization in Europe related to the initial marketing authorization. The Type II Variation application for Bosulif for adults with newly diagnosed chronic phase Ph+ CML was based on results from BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment), a randomized multicenter, multinational, open-label, phase III, head-to-head study of Boulif 400 mg versus imatinib 400 mg, a current standard of care. Pfizer and Avillion entered into an exclusive collaborative development agreement in 2014 to conduct the BFORE trial. Under the terms of the agreement, Avillion provided funding for the trial to generate the clinical data used to support this application and other potential regulatory filings for marketing authorization for Bosulif as first-line treatment for patients with chronic phase Ph+ CML. Pfizer retains all rights to commercialize Bosulif globally.