Pfizer sought CHMP Opinion for MYLOTARG and BOSULIF

Pfizer asserted that that the Committee for Medicinal products for Human use of the European Medicines Agency has adopted positive opinions extending marketing authorizations in the EU to the two Pfizer hematology medicines. MYLOTARG 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).

Mace Rothenberg, M.D., 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.”

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.

The Marketing Authorization Application (MAA) for MYLOTARG was based on data from an investigator-led, Phase 3, randomized, open-label study (ALFA-0701) in previously untreated, de novo patients.