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Pfizer Inc. ( PFE - Analyst Report ) recently received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its oncology candidate, bosutinib.
Pfizer is looking to gain conditional approval for bosutinib in the EU for the treatment of adults suffering from chronic, accelerated, and blast phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) that has been previously treated with one or more tyrosine kinase inhibitors (TKIs) and for whom treatments like Novartis’ ( NVS - Snapshot Report ) Gleevec (imatinib) and Tasigna (nilotinib) and Bristol-Myers Squibb’s ( BMY - Analyst Report ) Sprycel (dasatinib) are not considered suitable.
The CHMP’s opinion was based on data from the global, single-arm, open-label, multi-cohort, phase I/II Study 200, which was conducted in more than 500 patients suffering from Ph+ CML.
With the CHMP issuing a positive opinion, we expect the candidate to gain EU approval shortly. We note that bosutinib is already approved in the US under the brand name Bosulif. Pfizer gained US Food and Drug Administration (FDA) approval in Sep 2012 for Bosulif for the treatment of chronic, accelerated, or blast phase Ph+ CML in adult patients who are resistant or intolerant to prior therapy. Bosulif enjoys orphan drug status in the US.
Pfizer currently carries a Zacks Rank #3 (Hold). While near-term earnings will be driven by cost cutting efforts and share repurchases, longer-term growth will depend on the success of drug development. Pfizer’s pipeline needs to deliver given the Lipitor loss of exclusivity and the upcoming loss of exclusivity on additional products in the next few years.
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