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Home Industry News Pfizer receives CHMP backing for haematology drugs Mylotarg and Bosulif

Pfizer receives CHMP backing for haematology drugs Mylotarg and Bosulif

27th February 2018

Pfizer has announced that two of its haematology medicines for the treatment of leukaemia have been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending that Mylotarg be approved in combination with daunorubicin and cytarabine for the treatment of patients aged 15 years and older with previously-untreated CD33-positive acute myeloid leukaemia.

Meanwhile, Bosulif has been recommended for the treatment of adults with newly-diagnosed chronic-phase Philadelphia chromosome-positive chronic myelogenous leukaemia, with both recommendations now set to be independently reviewed by the European Commission.

Both drugs have demonstrated considerable potential in phase III clinical studies, with Bosulif developed as part of a clinical collaboration with Avillion.

Dr Mace Rothenberg, chief development officer for oncology at 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 leukaemia who would typically be treated with chemotherapy alone."

He added that the potential expansion of the approved use of Bosulif will offer new therapeutic options for adult patients with newly-diagnosed chronic myelogenous leukaemia.

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