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IMBRUVICA (ibrutinib), Bruton’s tyrosine kinase (BTK) inhibitor

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).



Actual benefit

Non précisé


Improvement in actual benefit

III (modéré)


Therapeutic use


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