AstraZeneca’s Truqap in combination with Faslodex has been recommended for approval in the European Union for the treatment of adult patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen, AstraZeneca reported. The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency based its positive opinion on the results from the CAPItello-291 Phase III trial published in The New England Journal of Medicine, the company stated.
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