NDAORALCAPSULEPriority Review
Approved
Sep 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
BOSULIF (bosutinib) by Pfizer is tki. Approved for chronic myeloid leukemia. First approved in 2023.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BOSULIF (bosutinib) is an oral tyrosine kinase inhibitor (TKI) developed by Pfizer for the treatment of chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML) in adults and older patients. The drug inhibits BCR-ABL kinase and Src-family kinases, demonstrating activity against 16 of 18 imatinib-resistant BCR-ABL mutants, though it does not inhibit T315I and V299L variants. It is indicated for newly-diagnosed CML patients, those resistant to prior therapy, and those intolerant of previous treatments. BOSULIF occupies a niche position in the CML treatment landscape as a second-line or alternative TKI option when first-line agents fail or are not tolerated.
$0.2BPart D
8.3 years to LOEMechanism of Action
TKI. Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck. Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL kinase expressed in murine myeloid cell lines. Bosutinib did not inhibit the T315I and V299L…
Indications (1)
Clinical Trials (20)
A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).
Started Jan 2025
600 enrolled
Chronic Leukemia Myelogenous
Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule
Started Jan 2022
32 enrolled
Healthy Participants
Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
Started Oct 2021
17 enrolled
Myeloid Leukemia
A Study to Evaluate Available Treatment Information of Ponatinib, Bosutinib, Imatinib, Dasatinib and Nilotinib in Adults With Chronic Myeloid Leukemia
Started Oct 2021
1,769 enrolled
Leukemia
Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
Started Aug 2021
18 enrolled
Healthy Participants
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.