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BOSULIF offers proven efficacy for patients with resistance or intolerance to prior therapy 2
In 2nd-line treatment, after imatinib (n=266 evaluable) a
34
%
of patients
53
%
of patients
achieved MCyR at 6 months achieved MCyR with a minimum
follow-up of 23 months
(95% CI: 28.2, 39.9)
Median duration of MCyR was not
reached at the time of analysis
53% of patients with MCyR maintained
MCyR for at least 18 months (with a
minimum follow-up of 23 months)
In 3rd-line treatment, after imatinib followed by nilotinib and/or dasatinib therapy (n=108 evaluable)
• 27% of patients achieved MCyR by 6 months (95% CI: 18.8, 36.2)
• 32% of patients achieved MCyR with a minimum follow-up of 13 months
• Median duration of MCyR was not reached at the time of analysis
— 51% of patients with MCyR maintained MCyR for at least 9 months (with a minimum follow-up of 13 months)
BOSULIF has a distinct safety and tolerability profile 2
Warnings and precautions include: gastrointestinal toxicity, myelosuppression, hepatic toxicity, fluid retention, renal toxicity, and embryofetal
toxicity. Please see Important Safety Information below for more detail.
Most common adverse reactions observed in >20% of
patients in the Phase 1/2 safety population (N=546)
Most common Grade 3/4 adverse reactions
observed in ≥10% of patients
All grades (%)
Grade 3/4 (%)
Nausea (46) Anemia (27) Anemia (13)
Thrombocytopen ia (41) Pyrexia (26) Neutropenia (12)
Vomiting (39) Fatigue (24)
Abdominal pain (37)
a
Median duration of treatment was 22 months for evaluable patients.
MCyR=major cytogenetic response.
For more information on BOSULIF, visit www.BosulifHCP.com.
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 fatigue. The most common Grade 3/4 adverse reactions
and laboratory abnormalities observed in greater than 10% of patients were
thrombocytopenia, anemia, and neutropenia.
CYP3A Inhibitors and Inducers: Avoid concurrent use with strong or moderate
CYP3A inhibitors or inducers.
Proton Pump Inhibitors: Consider using short-acting antacids or H2 blockers
instead of PPIs to avoid a reduction in BOSULIF exposure. Separate antacid or
H2 blocker dosing and BOSULIF dosing by more than 2 hours.
Nursing Mothers: Given the potential for serious adverse reactions in nursing
infants, a decision should be made whether to discontinue nursing or BOSULIF,
taking into account the importance of the drug to the mother.
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Chronic Myelogenous Leukemia V.1.2016. © National Comprehensive Cancer Network, Inc.
2015. All rights reserved. Accessed October 27, 2015. To view the most recent and complete version of the
guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®,
and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
2. BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
Please see brief summary of full Prescribing Information on the following pages.
PP-BOS-USA-0288-01 © 2016 Pfizer Inc. All rights reserved. July 2016
Thrombocytopenia (29)
Rash (35) Diarrhea (82)