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

Shots:

• 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

Click here to read full press release/ article | Ref: Business Wire | Image: Behnace Net