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Imbruvica wins wider European leukaemia licence

AbbVie and J&J’s first-in-class drug now approved to treat all CLL patients in the EU
European Commission

AbbVie and Johnson & Johnson have been granted a European licence for the expanded use of their chemotherapy alternative drug Imbruvica.

The new marketing authorisation means all adult patients with chronic lymphocytic leukaemia (CLL) can be treated with Imbruvica, regardless of their treatment history.

First approved in October 2014 as a second-line therapy for CLL and mantle cell lymphoma (MCL) patients who had already received one prior treatment, the blockbuster drug is now the first chemotherapy-free option for newly-diagnosed CLL patients.

The green light by the European Commission comes on the back of a recommendation of the drug by the CHMP last month, and follows the FDA's earlier approval of the broadened indication in March.

Results from the RESONATE-2 trial formed the basis of Imbruvica's approval for both regulators, with the study comparing AbbVie and J&J's drug to chlorambucil in 269 treatment-naïve CLL patients aged 65 years or older.

The trial reported impressive efficacy in extending progression-free survival - 84% in comparison with chlorambucil - and the product also achieved partial or complete responses in 82% of patients versus 35% in the chemotherapy group.

With the expanded patient populations for Europe and the US Imbruvica looks set to meet analysts' sales forecasts in which projected peak sales are predicted to reach close to $10bn.

However, whether UK patients will be able to access the drug through the NHS is uncertain following NICE draft guidance rejecting the drug earlier this year.

Despite Imbruvica's status as the most requested CLL drug available on the Cancer Drugs Fund (CDF), the cost-effectiveness watchdog claimed that it was not minded to approve an NHS prescription due to “numerous uncertainties in the evidence base and modeling” for the drug, sparking widespread criticism of the committee's appraisal process.

A slow-progressing cancer of the bone marrow and blood cancer, CLL is currently the most common leukaemia in adults in western countries with approximately 14,600 people are diagnosed each year in the US alone.

Article by
Rebecca Clifford

1st June 2016

From: Regulatory



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