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By Michael Dabaie
Pfizer Inc. (PFE) said Wednesday the European Commission approved Vizimpro as monotherapy for the first-line treatment of lung cancer.
The EC approved Vizimpro for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations. The EC's approval was supported by data from the Archer 1050 Phase 3 study. The primary endpoint was progression-free survival as determined by blinded Independent Radiologic Central review. A statistically significant improvement in PFS as determined by the IRC was demonstrated, the company said.
In 2012, Pfizer and SFJ Pharmaceuticals agreed to conduct the Archer 1050 study across multiple sites. SFJ Pharmaceuticals provided the funding and conducted the trial to generate the clinical data used to support this application. Pfizer retains all rights to commercialize Vizimpro globally.
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(END) Dow Jones Newswires
April 03, 2019 10:18 ET (14:18 GMT)
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