Pfizer’s breast cancer drug gets EU approval

pharmafile | November 10, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, EU, Novartis, Pfizer, ibrance 

Pfizer is celebrating the approval by the European Union of its breast cancer drug Ibrance, following a positive recommendation from the European Medicines Agency (EMA) in September.

The approval means that Ibrance is the first treatment of its kind to hit the European market. The drug blocks cyclin-dependent kinases 4 and 6 and is designed to be used as a combination therapy in patients whose tumours grow in response to oestrogen and whose cancer is not caused by the HER2 protein. The new clearance covers the use of the drug in tandem with AstraZeneca’s Faslodex in those who have previously received endocrine therapy.

Ibrance, which received approval in February 2015 in the US, is expected to generate sales of around $2.1 billion, according to analysts.

Novartis meanwhile is working on getting its rival drug ribociclib to market after publishing positive clinical data; the company plans to file for regulatory approval worldwide before the end of the year.

Matt Fellows

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