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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Ref: Business Wire | Image: Janssen