Posted by Michael Wonder on 24 Feb 2018
Pfizer receives positive CHMP opinion for two haematology medicines, Mylotarg and Bosulif
23 February 2018 - Pfizer today announced that the CHMP of the EMA has adopted positive opinions recommending that two Pfizer haematology medicines be granted marketing authorisations in the European Union.
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 leukaemia, except acute promyelocytic leukaemia.
Bosulif (bosutinib) has been granted a positive opinion for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia. The CHMP’s opinions for both medicines will now be reviewed separately by the European Commission.
