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NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended approval of alpelisib (Novartis' Piqray) in combination with fulvestrant for PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer that has progressed on endocrine therapy. The drug is recommended for women who are postmenopausal and men with breast cancer.

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