IMBRUVICA (ibrutinib), Bruton’s tyrosine kinase (BTK) inhibitor
Reason for request
Moderate improvement in chronic lymphocytic leukaemia in second-line and subsequent therapy, and in the first line in case of 17p deletion or TP53 mutation.
Minor improvement in patients with relapsed or refractory mantle cell lymphoma
- IMBRUVICA has Marketing Authorisation in two indications:
- treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy;
- treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
- In the second-line and subsequent treatment of CLL, IMBRUVICA showed an improvement in progression-free survival and overall survival by comparison with ARZERRA (ofatumumab). In 1st-line treatment of patients with a 17p deletion (del17p) or TP53 mutation, efficacy data are limited.
- In relapsed or refractory MCL, the therapeutic contribution was observed in a non-comparative study based on the overall response rate, after two or more failures. IMBRUVICA as monotherapy is a next-line treatment in patients with relapsed or refractory MCL.
Improvement in actual benefit