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news.Pfizer has received European approval to market its drug Aromasin for treatment of estrogen-related early breast cancer, following two to three years of initial tamoxifen therapy in postmenopausal women.
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Aromasin (exemestane) is a hormonal therapy, used to treat women with breast cancers that depend on a hormone, specifically estrogen, for growth and survival. An estimated two-thirds of breast cancer cases are estrogen dependent.
The European approval was based on a study that showed patients who switched to Aromasin after two to three years of tamoxifen had a 31% better probability of disease-free survival than those who remained on tamoxifen.
“All patients deserve to have the greatest possibility of living disease-free. For too long, patients with breast cancer have simply been given tamoxifen for five years hoping that it works. Patients now have an extra option – at no increased risk in terms of side effects,” said Professor Charles Coombes of Imperial College, Hammersmith Hospital, London and lead investigator of the study. “They can simply switch after two-to-three years of taking tamoxifen to exemestane.”
The UK acted as the reference member state for the European mutual recognition variation procedure, which covers 15 other countries. Subsequently, the UK national approval was granted, and similar national approvals in the rest of the MRP countries of the new early breast cancer indication are expected in the near future.
Aromasin has also been newly approved for use in early breast cancer in Switzerland and New Zealand.