- Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed
BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative
Chronic Myeloid Leukemia (from initial diagnosis).
- Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib
and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).
- Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to
receive treatment with imatinib, dasatinib and/or nilotinib for any reason.
- Participation in any other clinical studies involving investigational drug(s) within
14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to
the first dose of bosutinib.
- Prior treatment with bosutinib.
- Prior treatment with ponatinib.
- Known T315I or V299L mutation.