Reddy-Bosutinib

Bosutinib

• Brand(s): Bosulif
• Dosage Form/Strength: 100 mg, 500 mg tablet
• (Last Update: September 3, 2020)

For the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in patients meeting the following criteria:

1. 18 years of age or older; AND

2. Diagnosis of (Ph+) chronic phase, accelerated phase, or blast phase CML; AND

3. Bosutinib is used in one of the following clinical situations:
   i) As second line therapy after experiencing disease progression on imatinib, dasatinib, or nilotinib¹ in first line;
   OR
   ii) As third line therapy after experiencing disease progression to imatinib, dasatinib, nilotinib¹, or ponatinib in second line;
   OR
   iii) In patients who have not progressed on one or more prior TKIs but who have documented mutational drug resistance to imatinib, dasatinib, and/or nilotinib¹ which make them clinically inappropriate treatment choices;
   OR
   iv) In patients who have not progressed on one or more TKIs but have experienced unacceptable intolerance or toxicity to one prior TKI (i.e., imatinib, dasatinib, or nilotinib¹)

Exclusion Criteria:

• Bosutinib will not be funded in combination with another oral TKI (e.g., imatinib, nilotinib, dasatinib, or ponatinib)
• Bosutinib will not be funded as 4^th line treatment for CML or beyond.

¹Note that nilotinib is not funded in blast phase CML, therefore, considerations will only be applied for imatinib and dasatinib in patients with blast phase CML

Renewal criteria:
Renewal of funding will be considered upon confirmation from the patient’s clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so

Recommended Dosing: 500mg per day

Approval period for initials & renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests