PIQRAY (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
PIQRAY
Date registered
Evaluation commenced
Decision date
Approval time
195 working days (255)
Active ingredients
alpelisib
Registration type
NCE/NBE
Indication
PIQRAY (film coated tablet) in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation as detected by a validated test following progression on or after an endocrine-based regimen.