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

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