Pfizer’s BOSULIF® (bosutinib) Receives Conditional Marketing Authorization From The European Commission

Thu Mar 28, 2013 3:00am EDT

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NEW YORK--(Business Wire)--
Pfizer Inc. announced today that the European Commission (EC) has granted
conditional marketing authorization for BOSULIF (bosutinib) in the European
Union (EU) for the treatment of adult patients with chronic phase (CP),
accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive
chronic myelogenous leukemia (Ph+ CML) previously treated with one or more
tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and
dasatinib are not considered appropriate treatment options.1

"I`m delighted the EC has approved BOSULIF as a new addition to the CML
treatment landscape in Europe," said Carlo Gambacorti-Passerini, MD, Professor
of Internal Medicine at the University of Milano Bicocca in Italy, Director of
the Clinical Research Unit, Section of Hematology at S. Gerardo Hospital in
Monza, Italy, and a lead investigator in the BOSULIF clinical study. "It`s
critical to have additional treatment options for CML patients, because each
patient responds to therapy differently and has unique needs. Based on my
experience with BOSULIF, I believe this once-daily treatment, with its distinct
safety profile, offers an important new alternative." 

Conditional marketing authorizations in the EU are granted to medicinal products
with a positive benefit/risk assessment that address unmet medical needs and
whose availability would result in a significant public health benefit. A
conditional marketing authorization is renewable annually. As part of the
conditional approval, Pfizer is committed to generating additional efficacy and
safety data for BOSULIF in patients with Ph+ CML previously treated with one or
more TKIs not suitable for imatinib, dasatinib and nilotinib, and will submit
the findings to the European Medicines Agency (EMA). Following review of the
data by the EMA`s Committee for Medicinal Products for Human Use (CHMP), the EC
will consider converting the conditional marketing authorization to a full
marketing authorization. 

The EC decision was based on data from Study 200, a global, single-arm,
open-label, multi-cohort, Phase 1/2 study of BOSULIF in more than 500 patients
with Ph+ CML who had previously been treated with at least one TKI. The study
included separate cohorts for patients with chronic, accelerated and blast phase
disease. Data on 52 patients were considered as main evidence for the
conditional marketing authorization, as these patients were identified as having
an unmet medical need because other TKIs were not considered appropriate
treatment options for them due to disease resistance or the risk of severe side

"The approval of BOSULIF reflects the progress that is being made to address the
unmet needs of CML patients in Europe and exemplifies Pfizer`s commitment to
bringing meaningful new medicines to patients living with hematologic
malignancies," said Andreas Penk, Regional President of Europe for the Pfizer
Oncology Business Unit. 

About BOSULIF (bosutinib)

BOSULIF is an oral, once-daily, kinase inhibitor, which limits cancer cell
growth by inhibiting the Abl and Src signaling pathways.2 The recommended dose
of BOSULIF is 500 mg, orally, taken once daily with food.1 BOSULIF was first
approved in the U.S. in September 2012 for the treatment of adult patients with
chronic, accelerated or blast phase Ph+ CML with resistance, or intolerance, to
prior therapy.3

Important BOSULIF (bosutinib) U.S. Safety Information

Contraindication: Hypersensitivity to BOSULIF. Anaphylactic shock occurred in
less than 0.2% of treated patients. 

Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain can
occur. In the clinical trial, median time to onset for diarrhea was 2 days,
median duration was 1 day, and median number of episodes per patient was 3
(range 1-221). Monitor and manage patients using standards of care, including
antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce, or
discontinue BOSULIF as necessary. 

Myelosuppression: Thrombocytopenia, anemia, and neutropenia can occur. A
complete blood count should be performed weekly for the first month and then
monthly or as clinically indicated. Withhold, dose reduce, or discontinue
BOSULIF as necessary. 

Hepatic Toxicity: Twenty percent of patients experienced an increase in either
alanine aminotransferase (ALT) or aspartate aminotransferase (AST). Liver enzyme
elevation usually occurs early in treatment. Perform monthly hepatic enzyme
tests for the first 3 months and as clinically indicated. In patients with
transaminase elevations, monitor liver enzymes more frequently. Drug-induced
liver injury has occurred. Withhold, dose reduce, or discontinue BOSULIF as

Fluid Retention: Fluid retention can occur and may cause pericardial effusion,
pleural effusion, pulmonary edema, and/or peripheral edema. Monitor and manage
patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF
as necessary. 

Embryofetal Toxicity: BOSULIF may cause fetal harm when administered to a
pregnant woman. Women of childbearing potential should be advised of potential
hazard to the fetus and to avoid becoming pregnant while receiving BOSULIF. 

Adverse Reactions: The most common adverse reactions observed in greater than
20% of patients in the Phase 1/2 safety population (N=546) were diarrhea,
nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and

The most common Grade 3/4 adverse reactions and laboratory abnormalities
observed in greater than 10% of patients were thrombocytopenia, anemia, and

Drug Interactions: Avoid concurrent use with strong or moderate CYP3A inhibitors
or inducers. 

Proton Pump Inhibitors (PPIs): Consider using short-acting antacids or H2
blockers instead of PPIs. Separate antacid or H2 blocker dosing and BOSULIF
dosing by more than 2 hours. 

Substrates of P-glycoprotein: BOSULIF may increase the plasma concentrations of
drugs that are P-gp substrates, such as digoxin. 

Nursing Mothers: Given the potential for serious adverse reactions in nursing
infants, a decision should be made whether to discontinue nursing or BOSULIF. 

Hepatic Impairment: Treat with a dose of 200 mg daily in patients with any
baseline hepatic impairment. 

For more information and full prescribing information, please visit 

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and development of
innovative treatment options to improve the outlook for cancer patients

Hematologic cancers are a complex group of diseases, with over 70 different
types of lymphomas, leukemias or myelomas. While there have been significant
advancements in the treatment of some hematologic cancers, there continues to be
a need for additional therapeutic options. Pfizer Oncology is committed to
improving outcomes for patients living with hematologic malignancies like CML.
Pfizer Oncology has a robust hematology pipeline, with biologics and small
molecules in clinical development across a number of hematologic malignancies.
We are advancing technologies as well as working to identify new and innovative
options that address specific hematologic cancers, molecular subtypes, gene
over-expression and mechanisms of resistance. 

For more information, please visit 

DISCLOSURE NOTICE: The information contained in this release is as of March 28,
2013. Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future events or

This release contains forward-looking information that involves substantial
risks and uncertainties about an oncology product, BOSULIF. Such risks and
uncertainties include, among other things, whether and when the European
Commission (EC) will convert the conditional marketing authorization for BOSULIF
to a full marketing authorization in the EU, as well as the EC`sdecisions
regarding labeling and other matters that could affect BOSULIF`s availability or
commercial potential in the EU; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer`s Annual
Report on Form 10-K for the fiscal year ended December 31, 2012 and in its
reports on Form 10-Q and Form 8-K.

1 Summary of Product Characteristics (SmPC) for BOSULIF. Sandwich, Kent: UK;

2 Konig H. Effects of Dasatinib on Src Kinase Activity and Downstream
Intracellular Signaling in Primitive Chronic Myelogenous Leukemia Hematopoietic
Cells. Cancer Research. 2008; 68: 9624-9633. 

3 BOSULIF (bosutinib) Prescribing Information. New York, NY: Pfizer, Inc.;

Lisa O`Neill, (+44) 7929-339-560
Victoria Davis, (+1) 347-558-3455
Suzanne Harnett, (+1) 212-733-8009 

Copyright Business Wire 2013

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