alpelisib tablets, for oral use Initial U.S. Approval: 2019
As specified in the prescribing information, alpelisib tablets is indicated for the treatment of Breast Cancer. Piqray (alpelisib) is a medication used in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Facts about alpelisib tablets
DISEASE INDICATIONS-Breast Cancer
MANUFACTURER-Novartis
USAGE-Oral
MEDICINE APPROVED BY-European Medical Agency (EMA), Food and Drug Administration (FDA)
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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