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Published on: September 18, 2013
Bosutinib: Pediatric First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.
Insights
Bosutinib is now approved in the USA for treating pediatric patients with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). This milestone follows its established use in adults with this condition.
Area of Science:
- Oncology
- Pharmacology
- Hematology
Background:
- Bosutinib (BOSULIF®) is an oral BCR-ABL tyrosine kinase inhibitor (TKI).
- It is approved in the EU and USA for adult Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase (CP), accelerated phase (AP), and blast phase (BP), both newly diagnosed (ND) and resistant/intolerant (R/I) to prior therapy.
Purpose of the Study:
- To summarize the development of bosutinib leading to its pediatric approval.
- To highlight the clinical data supporting bosutinib's use in pediatric Ph+ CML.
Main Methods:
- Review of clinical development milestones for bosutinib.
- Analysis of clinical data in pediatric patients aged 1 to <18 years with Ph+ CML.
Main Results:
- Bosutinib was approved in the USA in September 2023 for pediatric patients aged ≥1 year with ND or R/I CP Ph+ CML.
- This approval was based on clinical data from pediatric patients.
Conclusions:
- Bosutinib represents a new treatment option for pediatric patients with Ph+ CML.
- The drug's development pathway has now extended to include younger patient populations.
Abstract:
Bosutinib (BOSULIF®), an orally administered BCR-ABL tyrosine kinase inhibitor (TKI) developed by Pfizer Inc., is well established in the EU and the USA as a treatment for adults with newly diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), and for CP, accelerated phase and blast phase Ph+ CML that is resistant or intolerant (R/I) to prior therapy. In September 2023, based on clinical data from patients aged ≥ 1 to < 18 years, bosutinib was approved in the USA for the treatment of pediatric patients aged ≥ 1 year with CP Ph+ CML that is ND or R/I to prior therapy. This article summarizes the milestones in the development of bosutinib leading to this first pediatric approval.
