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Pfizer Gets Positive CHMP Opinion For Mylotarg And Bosulif - Quick Facts

Pfizer Inc. (PFE) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency (EMA) has adopted positive opinions recommending that two of the company's hematology medicines be granted marketing authorizations in the European Union or EU.

Mylotarg or gemtuzumab ozogamicin, in combination with daunorubicin and cytarabine, has been granted a positive opinion by the CHMP for the treatment of patients aged 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia or AML, except acute promyelocytic leukemia or APL.

Bosulif or 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 or EC.

Mace Rothenberg, chief development officer, Oncology, Pfizer Global Product Development, said, "If approved, the addition of MYLOTARG to standard chemotherapy will provide an important new treatment option for patients with acute myeloid leukemia who would typically be treated with chemotherapy alone. Additionally, the potential expansion of the approved use of BOSULIF to include first-line therapy expands the treatment options for adult patients with newly diagnosed chronic myelogenous leukemia."

According to Pfizer, Mylotarg's Marketing Authorization Application or MAA was based on data from an investigator-led, Phase 3, randomized, open-label study or ALFA-0701 in previously untreated, de novo patients.

Pfizer noted that Bosulif currently has conditional marketing authorization in Europe related to the initial marketing authorization.

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