Pfizer receives CHMP recommendation for leukaemia drug

Pharmaceutical Company Product News

Pfizer has been granted a European regulatory recommendation for approval of its investigational leukaemia therapy bosutinib, which is sold under the name Bosulif in the US.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the drug for the treatment of adult patients with chronic, accelerated  and blast phase Philadelphia chromosome=positive chronic myelogenous leukemia who have been previously treated with one or more tyrosine kinase inhibitors.

It is intended for patients for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options and has demonstrated its efficacy in clinical studies.

The CHMP has recommended bosutinib for a conditional European approval, based on its positive benefit/risk profile and its potential to address unmet medical needs.

Dr Mace Rothenberg, senior vice-president of clinical development and medical affairs at Pfizer's oncology business unit, said: "We believe many doctors and CML patients will find this treatment, if approved, to be a welcome addition, offering a distinct adverse event profile and a convenient once-daily dosing regimen."

This comes after the company received European approval to expand the use of its pneumococcal conjugate vaccine Prevenar 13 to older children and adolescents aged between six and 17 years old last week.

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