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Home Industry News Pfizer’s Ibrance receives new breast cancer approval in Europe

Pfizer’s Ibrance receives new breast cancer approval in Europe

11th November 2016

Pfizer has announced that its cancer drug Ibrance has been approved by the European Commission in a new breast cancer indication.

The drug has been approved for use among women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer, when administered in combination with an aromatase inhibitor.

This approval also covers the use of Ibrance in combination with fulvestrant in women who have received prior endocrine therapy, and is based on positive data from clinical studies.

In a number of phase II and III trials, Ibrance in combination with an endocrine therapy was shown to significantly prolong progression-free survival, compared to endocrine therapy alone.

Ibrance becomes the first medicine to be approved in Europe that works by inhibiting cyclin-dependent kinases 4 and 6, as well as being the first medicine approved for this type of metastatic breast cancer in the first-line setting in nearly a decade.

Dr Andreas Penk, regional president for international developed markets at Pfizer Oncology, said: "With strong and consistent data in three pivotal clinical studies and rapid adoption as a standard of care in the US, Ibrance represents a potential new benchmark for the treatment of HR+/HER2- metastatic breast cancer in Europe."

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