By Saabira Chaudhuri
Pfizer Inc. (>> Pfizer Inc.) said the European Medicines Agency (EMA) issued a positive opinion about the conditional marketing authorization of its cancer drug bosutinib in the European Union for the treatment of adult patients with certain types of leukemia.
Pfizer said the positive opinion was adopted by the Committee for Medicinal Products for Human Use and relates to chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitor and for whom imatinib, nilotinib and dasatinib aren't considered appropriate treatment options.
Conditional approvals in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit.
Bosutinib is an oral, once-daily, kinase inhibitor, which limits cancer cell growth by inhibiting certain signaling pathways.
Pfizer noted that chronic myelogenous leukemia accounts for 15% of all leukemia cases and that, despite the availability of existing treatments for the condition, there remains a need for additional treatment options.
"We believe that bosutinib, if approved by the European Commission, would represent an important option for patients with CML who have progressed on prior treatment and are not candidates for alternative treatments," said Mace Rothenberg, senior vice president of clinical development and medical affairs at the Pfizer Oncology Business Unit. "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."
Shares were flat at $26.83 in recent premarket trading. The stock has risen 22% in the past 12 months.
Write to Saabira Chaudhuri at [email protected]
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