CHMP recommends approval of Imbruvica (ibrutinib) for Waldenstr�m's macroglobulinemia- Pharmacyclics

The CHMP of the European Medicines Agency issued a positive opinion recommending a change to the terms of the marketing authorization for Imbruvica (ibrutinib), from Pharmacyclics, in the European Union to indicate the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

Updated results from the study were published on in the April 9, 2015 edition of The New England Journal of Medicine, indicating an ORR of 90.5% after a median duration of treatment of 19.1 months using criteria adopted from the International Workshop on WM. At 24 months, the estimated rate of progression-free survival was 69.1% (95% CI, 53.2 to 80.5), and the estimated rate of overall survival was 95.2% (95% CI, 86.0 to 98.4). No new safety issues were observed in the clinical trial. The most commonly occurring adverse reactions in WM patients treated with Imbruvica (>20%) were neutropenia and thrombocytopenia.