FDA — authorised 24 May 2019
- Application: NDA212526
- Marketing authorisation holder: NOVARTIS
- Local brand name: PIQRAY
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Piqray in United States
FDA authorised Piqray on 24 May 2019
Marketing authorisations
FDA — authorised 5 April 2022
- Application: NDA215039
- Marketing authorisation holder: NOVARTIS
- Local brand name: VIJOICE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Piqray, developed by Novartis, for the treatment of adult patients with HR-positive, HER2-negative, PIK3CA-mutated breast cancer. This approval is based on the results of a clinical trial demonstrating the efficacy of Piqray in this patient population. The approval was granted through the standard expedited pathway.
FDA — authorised 24 April 2024
- Application: NDA218466
- Marketing authorisation holder: NOVARTIS
- Local brand name: VIJOICE
- Indication: GRANULE — ORAL
- Status: approved
The FDA approved Piqray, developed by Novartis, for the treatment of adult patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer. This approval was granted based on a standard application pathway. Piqray is a kinase inhibitor that targets the PI3K/AKT pathway, which is involved in cancer cell growth and survival.
Piqray in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Piqray approved in United States?
Yes. FDA authorised it on 24 May 2019; FDA authorised it on 5 April 2022; FDA authorised it on 24 April 2024.
Who is the marketing authorisation holder for Piqray in United States?
NOVARTIS holds the US marketing authorisation.