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Pfizer Bases Bosutinib U.S. Filing On One Single-Arm Phase II Trial

 
• By Emily Hayes

FDA accepts NDA for dual Srk and Abl inhibitor bosutinib in previously-treated Philadelphia chromosome-positive CML on a positive news day for Pfizer. Meanwhile, review in front-line CML is pending in Europe.

Pfizer Inc.has made a single-arm, open-label Phase I/II study the basis of its NDA for bosutinib in previously treated Philadelphia chromosome-positive chronic myeloid leukemia, bypassing the failed Phase III BELA study in the front-line setting.

The company announced on Jan. 27 that the application had been accepted for review by FDA for adults with previously treated Ph+ CML following submission sometime in the fourth quarter...

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More from Approvals

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EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
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More from Product Reviews

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Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
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