Piqray (alpelisib)
- Region
- 🇪🇺 EU
- Active substance
- alpelisib
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 28 May 2020
- EU approval
- Mon 27 Jul 2020
- Application
- EMEA/H/C/004804
- ATC
- L01XE
- Official record
- www.ema.europa.eu
Indication
Piqray is indicated 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, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Vijoice Authorised · Novartis Europharm Limited
- 🇪🇺 Vijoice Application withdrawn · Novartis Europharm Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.