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.