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Janssen’s Imbruvica (ibrutinib) Receives EC’s Approval as a Fixed-Duration Combination Regimen for Chronic Lymphocytic Leukaemia

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Janssen’s Imbruvica (ibrutinib) Receives EC’s Approval as a Fixed-Duration Combination Regimen for Chronic Lymphocytic Leukaemia

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  • 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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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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