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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer’s NDA for dual Src and Abl inhibitor bosutinib in previously-treated Philadelphia chromosome-positive CML bypassed the failed first-line Phase III BELA trial. In Europe, BELA is the basis of a pending front-line CML application.

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