Pfizer's bosutinib has received positive opinion for the conditional marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
The bosutinib positive CHMP opinion is concerned with the conditional marketing authorization in the European Union for the treatment of different phases of philadelphia chromosome positive chronic myelogenous leukemia in patients who showed resistance or intolerance to previous therapy.
Pfizer oncology business unit clinical development and medical affairs senior vice president Mace Rothenberg said if the European Commission approves bosutinib it would be an important option for CML patients who received prior treatment and who are not suitable for alternative treatments.
"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," Rothenberg added.
Encouraging data from Study 200 Phase 1/2 study of bosutinib conducted in more than 500 patients with Ph+ CML who received prior treatment formed the basis for the positive opinion.
