Shots:
- The EC has approved a label extension for Imbruvica (ibrutinib) + R-CHOP alternating with R-DHAP (without ibrutinib), followed by ibrutinib monotx., for the treatment of previously untreated MCL pts ineligible for ASCT
- Approval was based on ongoing P-III (TRIANGLE) trial in 870 EU pts, assessing ibrutinib + chemoimmunotherapy (CIT) ± ASCT & 2yr. ibrutinib vs CIT followed by ASCT
- At mFU of 55mos., the trial showed superior failure-free survival (77% vs 68%) & OS (88% vs 78%) at 54mos., while avoiding the burden of ASCT
Ref: GlobeNewsWire| Image: Johnson & Johnson | Press Release
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