|
Active substance |
Alpelisib |
|
Holder |
Novartis Pharma |
|
Status |
Closed |
|
Indication |
In combination with fulvestrant or letrozole for postmenopausal women and men with endocrine resistant hormone receptor-positive (HR+) HER2-negative (HER2-) metastatic breast cancer, who have recurrence or progressed after at least 3 lines of systemic treatment for advanced or metastatic disease, and who harbor specific PIK3CA hotspot mutations. |
|
Public documents |
Approbation amendment |
|
Last update |
31/08/2021 |
Alpelisib
Last updated on 23/04/2024