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IMBRUVICA (ibrutinib), Bruton’s tyrosine kinase (BTK) inhibitor
ONCOLOGY - New indication
Opinions on drugs -
Posted on
May 11 2017
Reason for request
Extension of indication
No proven clinical advantage in the management of patients with chronic lymphocytic leukaemia who have not received prior therapy and are not eligible for fludarabine-based therapy
- IMBRUVICA has marketing authorisation in the treatment of chronic lymphocytic leukaemia (CLL) as a single agent in patients who have not received prior therapy.
- In a study including patients who were not eligible for full-dose fludarabine, progression-free survival was improved with IMBRUVICA (median duration not reached) versus a non-relevant comparator, chlorambucil used as a single agent (median duration 18.9 months).
- A network meta-analysis did not allow IMBRUVICA to be positioned in relation to its clinically relevant comparators.
- The main characteristics of IMBRUVICA safety profile of are haemorrhagic events and diarrhoea.
Clinical Benefit
| Substantial |
- |
| Insufficient |
Clinical Added Value
| minor |
- |
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