IMBRUVICA (ibrutinib) - Mantle cell lymphoma (MCL)

The clinical benefit of IMBRUVICA (ibrutinib) is low in the MA indication.

Considering:

• a suggested difference in failure-free survival (FFS) with an HR = 0.64 (CI two-sided98.33% [0.43; 0.95]) in the post-hocanalysis of ibrutinib compared to autologous stem cell transplantation based on a hypothesis that is the opposite of the initial hypothesis specified in the protocol, and a reformulation of the test (multiple analyses performed a posteriori);
• maintenance therapy with rituximab that was introduced during the study (without stratification at the time of randomisation);
• the absence of evidence relative to progression-free survival and overall survival (exploratory endpoints);
• the absence of a quality of life assessment;
• a safety profile marked by a higher frequency of serious adverse events in the ibrutinib group [I] compared to the autologous stem cell transplantation group [A] (64.5% vs. 45.9%) including grade ≥ 3 adverse events (55.1% vs. 39.2%). A lower frequency of adverse events associated with death in group I (2.3%) compared to group A (4.1%);

the Committee deems that IMBRUVICA (ibrutinib) provides no clinical added value (CAV V) compared to autologous stem cell transplantation.