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AstraZeneca: new indication for breast cancer drug Faslodex.

(CercleFinance.com) - AstraZeneca said on Monday that Europe's drugs regulator has given its backing for marketing approval to be granted for Faslodex in the treatment of hormone receptor-positive (HR+) breast cancer in women who have received endocrine therapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a new indication for the drug, which is already approved to treat ER+ advanced breast cancer patients.

AstraZeneca said the CHMP opinion is based on data from a Phase III trial showing the combination with targeted therapies such as Pfizer's palbociclib has resulted in a 4.9 month progression-free survival (PFS) improvement over placebo.

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