Bosutinib (3) – Bosulif®
Chronic myeloid leukaemia (CML), Ph+
Characteristics
| Start date | 01.09.2018 – Marketing authorisation: 27.03.2013 |
|---|---|
| Resolution | 21.02.2019 |
| INN | Bosutinib |
| Brand name | Bosulif® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-377 |
| ATC code | L01EA04 BCR-ABL tyrosine kinase inhibitors (L01EA) |
| ICD-10 codes (AIS) | C92.10Chronic myeloid leukemia, BCR/ABL-positive with failed remission, C92.11Chronic myeloid leukemia, BCR/ABL-positive, in remission |
| Alpha-ID codes (AIS) | I116135Chronic myeloid leukemia, Philadelphia chromosome (Ph1) positive, I31095CML (chronic myeloid leukemia) in complete remission |
| DDD | 0.5 g O |
| Therapeutic area | Oncological diseases Chronic myeloid leukemia (CML) |
| Reason for procedure |
Reassessment: Loss of orphan status
Original resolution: Bosutinib (1) (17.10.2013) |
| Regulatory status | Conditional Approval |
| Specialty | ACT change Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Bosulif is indicated for the treatment of adult patients with: Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML) during chronic phase (CP), accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP) of the disease who have been pretreated with at least one tyrosine kinase inhibitor (TKI) and for whom imatinib, nilotinib, and dasatinib are not considered appropriate treatment options | Ponatinib or interferon alfa |
| b) | Adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the accelerated phase (AP) and blast crisis (BK) of the disease who have been pretreated with at least one tyrosine kinase inhibitor (TKI) and for whom imatinib, nilotinib, and dasatinib are not considered appropriate treatment options | Ponatinib |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
| Reason for dividing into subpopulations (G-BA) | Patient eligibility |
| ACT change | 05.02.2019 – nach Dossiereinreichung, Stellungnahmeverfahren |
- Clinical trials
- In the dossier, the pharmaceutical manufacturer presents the results of the pivotal registration trial 3160A4-200-WW.
- The pharmaceutical manufacturer’s study portfolio also includes study 3160A4-2203.
- Both studies are single-arm studies, which do not allow for comparison with the appropriate comparator therapy.
Adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase (CP) of the disease who have been pre-treated with at least one tyrosine kinase inhibitor (TKI) and in whom imatinib, nilotinib and dasatinib are not considered suitable treatment options
- The additional benefit is not proven.
- An additional benefit compared with ponatinib is therefore not proven.
Adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the accelerated phase (AP) and in blast crisis (BC) of the disease, who have been pre-treated with at least one tyrosine kinase inhibitor (TKI) and for whom imatinib, nilotinib and dasatinib are not considered suitable treatment options
- An additional benefit is not proven.
- An additional benefit compared with ponatinib is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Bosutinib (4) | Bosulif® | Pfizer Pharma GmbH | Chronic myeloid leukaemia (CML), Ph+, first-line | 760–890 | 100% additional benefit not proven | |
| Bosutinib (3) | Bosulif® | Pfizer Pharma GmbH | Chronic myeloid leukaemia (CML), Ph+ | 545–555 | 100% additional benefit not proven | |
| Bosutinib (2) | Bosulif® | Pfizer Pharma GmbH | Chronic myeloid leukaemia (CML), Ph+, first-line |
0
690–810 |
100% additional benefit not proven repealed | |
| Bosutinib (1) | Bosulif® | Pfizer Pharma GmbH | Chronic myeloid leukaemia (CML) |
0
380–500 |
100% non-quantifiable additional benefit Orphan repealed |
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