Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

You may also be interested in...

Pfizer’s Bosulif Will Face Competitive Market In Second-Line CML

Approved by FDA Sept. 4, bosutinib will face off against two established tyrosine kinase inhibitors in the post-Gleevec treatment setting: Bristol’s Sprycel and Novartis’ Tasigna. Pfizer is highlighting Bosulif’s “distinct adverse event profile” and single-daily dosing to its advantage.

Pfizer Prices Bosulif With Eye Towards Leveling CML Playing Field

Pfizer enters crowded competition for previously treated Ph+ chronic myelogenous leukemia with the newly approved bosutinib, but the firm hopes having a comparable price will level the playing field.

Inlyta Approval Expands Pfizer Kidney Cancer Options, But With Unique Safety Profile

Second-generation VEGF inhibitor Inlyta (axitinib) gained approval based as much on its complementary safety profile as its superiority in a head-to-head comparison with Bayer/Onyx’s Nexavar .

Related Content


Related Companies




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts