Log in
Lost password
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Shares  >  Nyse  >  Pfizer Inc       

News SummaryMost relevantAll newsSector news 

Pfizer Inc. : Pfizer Gets Positive Opinion from EMA on Leukemia Drug Bosutinib

01/18/2013 | 08:46am US/Eastern
   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 saabira.chaudhuri@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

Stocks mentioned in the article : Pfizer Inc.
React to this article
Latest news on PFIZER INC
09:28a PFIZER : signs deal with College of Family Medicine Pakistan - Press Release iss..
08:16a PFIZER : signs an MOU signed with College of Family Medicine Pakistan
07:35a PFIZER : Alvogen to Acquire Four Pharma Products from Pfizer
06:54a PFIZER : Alliance Foundation Trials and Austrian Breast & Colorectal Cancer Stud..
03:07a BRISTOL MYERS SQUIBB : and Pfizer to Participate at the ESC Congress 2015
03:07a BRISTOL MYERS SQUIBB : and Pfizer to Report New Data on Eliquis (apixaban)
03:06a PFIZER : Secures Clearance from U.S. FTC for Hospira Acquisition
02:58a BRISTOL MYERS SQUIBB : and Pfizer to Report New Data on Eliquis (apixaban) at ES..
08/26 PFIZER : Alliance Foundation Trials and Austrian Breast & Colorectal Cancer Stud..
08/25 PFIZER : Immuron Appoints New Chief Executive Officer
Duration : Period :
Pfizer Inc Technical Analysis Chart | 4-Traders
Income Statement Evolution
More Financials