Janssen announces Health Canada approval of Imbruvica (ibrutinib) in combination with obinutuzumab for treatment naïve patients with chronic lymphocytic leukaemia

Janssen

8 November 2019 - Patients experienced a 77% reduction in risk of disease progression or death compared to chlorambucil plus obinutuzumab.

The Janssen Pharmaceutical Companies of Johnson & Johnson announces the Health Canada approval of Imbruvica (ibrutinib) in combination with obinutuzumab for treatment-naïve patients with active chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults. 

This is the ninth indication for Imbruvica in Canada since its first approval in November 2014 , and the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL.

Concurrently, the Imbruvica Product Monograph has been updated to include additional long-term efficacy data for Imbruvica use as a monotherapy in CLL, with five years of follow-up from the Phase 3 RESONATE (PCYC-1112) clinical trial and four years of follow-up from the Phase 3 RESONATE-2 (PCYC-1115) trial.

Read Janssen press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , Canada