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Janssen's Imbruvica (ibrutinib) Receives CHMP Positive Recommendation for its Expanded Use in Chronic Lymphocytic Leukaemia and Waldenstrom's Macroglobulinemia in Europe

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Janssen's Imbruvica (ibrutinib) Receives CHMP Positive Recommendation for its Expanded Use in Chronic Lymphocytic Leukaemia and Waldenstrom's Macroglobulinemia in Europe

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  • The CHMP’s positive opinion for CLL is based on P-III iLLUMINATE (PCYC1130) study assessing Imbruvica + obinutuzumab vs chlorambucil + obinutuzumab in patients with newly diagnosed CLL- resulted in longer m-PFS
  • The CHMP’s positive opinion for WM is based on P-III iNNOVATE (PCYC-1127) study evaluating the ibrutinib & rituximab vs rituximab + PBO in patients with relapsed/refractory WM resulted in m-PFS (79% vs 41%)
  • Imbruvica is a BTK inhibitor- co-developed by Janssen & Pharmacyclics with its CHMP’s positive opinion for both indications will be reviewed by European Commission

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Ref: Business Wire | Image: Janssen


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