IMBRUVICA (ibrutinib), Bruton’s tyrosine kinase (BTK) inhibitor
ONCOLOGY - Update
Opinions on drugs - Posted on Jul 11 2017
Reason for request
Re-assessment of the improvement in actual benefit
Moderate clinical added value compared to TORISEL in terms of progression-free survival and safety profile in the treatment of relapsed or refractory mantle cell lymphoma.
- IMBRUVICA has Marketing Authorisation in the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
- In one study, IMBRUVICA shows benefit in terms of progression-free survival compared to temsirolimus , without any difference in terms of overall survival between the IMBRUVICA and temsirolimus arms, in this disease where the medical need is partially covered.
- IMBRUVICA has shown a less unfavourable safety profile compared to temsirolimus in terms of grade ≥ 3 adverse events (67.6% versus 87.1%, respectively).
Improvement in actual benefit
Évaluation des médicaments