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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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The content of this website has been produced in line with the BOSULIF®▼ (bosutinib) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. BOSULIF Prescribing Information for Great Britain and for Northern Ireland, and adverse event reporting information can be found at the bottom of the page.

Efficacy data in 2nd line and beyond

Suitable for your intolerant and resistant CML patients1-3

BOSULIF has been tested in a large number of patients and demonstrates efficacy in a wide range of patient types

Patient cohorts (N = 574* including patients receiving ≥ 1 dose of BOSULIF)

Chronic phase, second line1
n=288

Primary cohort: imatinib resistant
(n-200)

Sub-group: Imatinib intolerant
(n=88)

Chronic phase, third-/fourth-line2
n=119

Sub-groups:
IMI-R/I + dasatinib
resistant (n=38)
IMI-R/I + dasatinib intolerant (n=50)
IMI-R/I + nilotinib
resistant (n=26)
IMI-R/I + nilotinib
Intolerant (n=5)

Accelerated phase3
n=79

Sub-group: Accelerated phase
(n=79)

Blast phase3
n=64

Sub-group: Blast phase (n=64)

*Includes 24 patients who were Ph+ ALL.3
†Third- and fourth-line subgroups comprise patients with CP CML that were imatinib resistant or imatinib intolerant and ≥ 1 of the following: Dasatinib resistant or dasatinib intolerant, nilotinib resistant, nilotinib intolerant or resistant/intolerant to dasatinib and nilotinib.

Efficacy in second-line patients and beyond2-5

Primary endpoint: 33% (95% CI, 27–40%) MCyR at 24 weeks in imatinib-resistant patients (n=200)1,5

Results show that the best cumulative response is either attained or maintained.

Response rates in all patients by line of therapy​​​​​​​

*Minimum follow-up period was 5 years (CP 2nd-line) or 4 years (CP 3rd-/4th-line and AP/BP).
Criteria used: Resistant mutation; medical history or evidence of prior TKI intolerance.

†Received ≥ 1 BOSULIF dose and had a valid baseline assessment for the corresponding endpoint. 
‡In patients with CP imatinib-resistant CML and no previous TKI exposure other than imatinib.

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Review ELN Guidelines

Compare 2013 guidelines to those published in 2020

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AP, accelerated phase; BP, blast phase; CCyR, complete cytogenetic response; CI, confidence interval; CML, chronic myeloid leukaemia; CP, chronic phase; ELN; European LeukemiaNet, IMI-R/I; imatinib resistant or intolerant, MCyR, major cytogenetic response; TKI, tyrosine kinase inhibitor.
 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
References:
  1. Cortes JE, et al. Blood 2011;118:4567–4576.
  2. Cortes JE, et al. Am J Hematol 2016;91:1206–1214.
  3. Gambacorti-Passerini C, et al. Am J Hematol 2015;90:755–768.
  4. Lipton JH, et al. Presented at ASCO, Chicago, IL, USA, 29 May–02 June 2015. Poster 7076.
  5. Cortes JE, et al. Blood 2011;118:4567–4576; erratum in Blood 2013;122:2524
PP-BOS-GBR-1303. September 2021

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PP-PFE-GBR-2688. December 2020

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