Janssen’s Imbruvica (ibrutinib) Receives European Commission Approval for Chronic Lymphocytic Leukaemia and Waldenstrom’s Macroglobulinemia in Adults

Janssen’s Imbruvica (ibrutinib) Receives European Commission Approval for Chronic Lymphocytic Leukaemia and Waldenstrom's Macroglobulinemia in Adults

Shots:

  • The approval is based on P-III iLLUMINATE (PCYC-1130) and P-III iNNOVATE (PCYC-1127) study assessing Imbruvica + obinutuzumab vs chlorambucil + obinutuzumab and Imbruvica + rituximab vs rituximab + PBO in patients with previously untreated CLL and r/r WM respectively
  • Collective results: improvement in PFS with the use of ibrutinib-based therapy vs SOC providing CT free options to the patients with blood cancer. The approval for the expanded use follows EMA’s CHMP positive opinion received on 28 Jun’2019
  • Imbruvica is a BTK inhibitor act by forming a covalent bond with BTK, blocking the transmission of cell survival signals within the malignant B-cells and is approved in 95+ countries for its multiple approved indications

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