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Piqray FDA Approval History

Last updated by Judith Stewart, BPharm on July 1, 2019.

FDA Approved: Yes (First approved May 24, 2019)
Brand name: Piqray
Generic name: alpelisib
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Breast Cancer

Piqray (alpelisib) is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR positive, HER2-negative, PIK3CA-mutated breast cancer.

Development timeline for Piqray

May 24, 2019Approval FDA Approves Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer
Dec  6, 2018Novartis Investigational BYL719 (alpelisib) Plus Fulvestrant Consistently Improved PFS in Patients with PIK3CA Mutated HR+/HER2- Advanced Breast Cancer in New SOLAR-1 Analyses
Oct 20, 2018Novartis investigational BYL719 (alpelisib) plus fulvestrant nearly doubles median PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer compared to fulvestrant alone

Further information

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