Pfizer receives EU conditional approval for Bosulif in CML

Pfizer announced Thursday that the European Commission (EC) issued a conditional marketing authorisation for Bosulif (bosutinib) for use in adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML). The oral, once-daily, kinase inhibitor is specifically indicated for patients who were previously treated with at least one tyrosine kinase inhibitor (TKI) and for whom other treatment options, including Novartis' Glivec (imatinib) and Tasigna (nilotinib) and Bristol-Myers Squibb's Sprycel (dasatinib), are considered inappropriate. The drugmaker indicated that the EC will consider awarding full marketing authorisation for the drug after a data review by European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP).

The commission's decision was supported by Study 200, a single-arm Phase I/II study of more than 500 patients with Ph+ CML who previously received treatment with at least one TKI. The company noted that the authorisation was based primarily on data from 52 patients, as these patients were considered to have an unmet clinical need because other TKIs were not appropriate for them because of adverse effects or disease resistance. Lead trial investigator Carlo Gambacorti-Passerini remarked that "it’s critical to have additional treatment options for CML patients, because each patient responds to therapy differently and has unique needs." He added that "based on my experience with Bosulif, I believe this once-daily treatment, with its distinct safety profile, offers an important new alternative."

The conditional approval follows a positive opinion from CHMP for use of the therapy in certain patients with CML. The FDA approved the drug in September 2012 for the same indication.

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