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AstraZeneca: EU approval in breast cancer

( - AstraZeneca announces the approval of its Truqap in combination with Faslodex in the European Union, for the treatment of adult patients with locally advanced or metastatic estrogen receptor (ER)-positive breast cancer.

This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use, and is based on the results of the CAPItello-291 phase III trial published in The New England Journal of Medicine.

Similar indications for Truqap in combination with Faslodex are already approved in the USA, Japan and several other countries. Regulatory submissions are currently under review in China and elsewhere.

Following this approval in the EU, Astex Therapeutics is eligible to receive a milestone payment from AstraZeneca on the first commercial sale of the drug in the EU, as well as royalties on future sales.

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