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Janssen-Cilag International NV

 

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Ibrutinib shown to be superior to chlorambucil in trial

7 December 2015 | By Victoria White

Janssen-Cilag International NV has announced data from the Phase 3 RESONATE-2 (PCYC-1115) trial that show ibrutinib (Imbruvica) was superior to chlorambucil in all efficacy endpoints measured in patients with treatment-naïve chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older.

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Janssen submits application to EMA to expand use of ibrutinib

4 November 2015 | By Victoria White

Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency (EMA), which seeks to broaden the existing marketing authorisation for Imbruvica (ibrutinib) to include previously untreated patients with chronic lymphocytic leukaemia (CLL).