Treats hormone receptor (HR)-positive, human epidermal growth … metastatic breast cancer. NDA 212526, held by Novartis. Alpelisib.
As of Nov 13, 2026, NDA 212526 (Piqray), held by Novartis, was first approved by FDA on May 24, 2019, with 6 approved supplements and 0 published complete response letters.
PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-authorized test following progression on or after an endocrine-based regimen.
| Jan 18, 2024 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Nov 22, 2022 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| May 24, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Oct 28, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Jan 18, 2024 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Nov 22, 2022 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| May 4, 2022 | Supplement 6Labeling · Standard review | Approved | |
| Jul 20, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Sep 1, 2020 | Supplement 1Labeling · Standard review | Approved | |
| May 24, 2019 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
