Janssen secures two positive CHMP opinions for Imbruvica label expansions
pharmafile | July 1, 2019 | News story | Sales and Marketing | CHMP, EMA, Europe, Janssen, imbruvica, pharma
Janssen’s Imbruvica (ibrutinib) has racked up two positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), it has been revealed.
While CHMP opinions are not binding, they are usually followed when it comes to passing a final verdict on whether to approve a product for market, meaning Imbruvica could soon see its label expanded.
The first expansion recommended by the CHMP was Imbruvica in combination with obinutuzumab in the treatment of previously untreated chronic lymphocytic leukaemia (CLL). This decision was reached based on Phase 3 data gathered on Imbruvica plus obinutuzumab compared to chlorambucil plus obinutuzumab in patients with newly diagnosed forms of the condition. After 31.3 months median follow-up, the Imbruvica combo was found to extend median progression-free survival (PFS) by a “significantly longer” duration.
The second expansion was in combination with rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). This ruling was supported by Phase 3 data which showed that Imbruvica in combination with rituximab led to a “significant improvement” in previously untreated and relapsed/refractory WM compared to rituximab plus placebo; estimated 30-month PFS rates stood at 79% for the Imbruvica combo compared to 41% for rituximab plus placebo.
“We are incredibly encouraged by these CHMP recommendations, which represent our continued commitment to develop chemotherapy-free combinations for those living with CLL and WM,” said Dr Patrick Laroche, Janssen’s Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA).“Ibrutinib has been used to treat more than 140,000 patients worldwide and we are continuing to deliver on our ambition to optimise outcomes for patients with complex B-cell malignancies, that have in the past been very difficult to treat.”
Dr Alessandra Tedeschi, investigator in the iNNOVATE and iLLUMINATE studies and Medical Director, Department of Hematology, at Niguarda Hospital, also remarked: “This is an important step forward in further enhancing our ability as haematologists to meet the treatment needs of more patients with these complex blood cancers. Ibrutinib has already offered important progress in both CLL and WM in the indications for which it is currently approved, and these new combination regimens show the potential to further extend the remission period for patients versus standard of care.”
Matt Fellows
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