Janssen’s Imbruvica (ibrutinib) Receives EC’s Approval as a Fixed-Duration Combination Regimen for Chronic Lymphocytic Leukaemia
Shots:
- The EC has granted marketing authorization for the expanded use of Imbruvica + venetoclax (I+V) in adults with prior untreated CLL
- The approval was based on the P-III (GLOW) study that evaluated I+V vs Clb+O in elderly patients aged ≥65yrs. with CLL/SLL which showed that I+V was superior to Clb+O, and improvement in PFS which was consistent across predefined subgroups
- The approval was also based on the FD cohort of the P-II (CAPTIVATE) study which showed deep & durable responses in patients with I+V, incl. those with high-risk features. The results were published in NEJM Evidence and Blood & the safety profile was consistent with safety profiles of I+V, 1.9% discontinued ibrutinib due to AF, and OS data is not mature with a median follow-up of 34mos.
Ref: J&J | Image: Janssen
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