Piqray Approved to Treat Breast Cancer
May 24, 2019 – The U.S. FDA has approved Piqray™ (alpelisib) tablets, manufactured by Novartis. Piqray is indicated for use in combination with fulvestrant to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer that has progressed in men or postmenopausal women who are on or have had treatment with an endocrine-based regimen.
The current standard of care for HR-positive breast cancer includes the use of endocrine therapy, such as fulvestrant. However, approximately 40% of patients who have HR-positive breast cancer have a PIK3CA mutation, which is associated with endocrine therapy resistance and disease progression. Piqray is the first FDA-approved medication for breast cancer that specifically targets this mutation.
In a clinical trial, patients treated with Piqray and fulvestrant had a median progression-free survival (PFS) time of 11 months compared to 5.7 months for those treated with a placebo and fulvestrant. Recommended dosing with Piqray is 300mg taken once daily. Fulvestrant dosing occurs on a 28-day cycle and requires two initial doses of 500mg administered via intramuscular injection on days 1 and 15 of the first cycle. In subsequent cycles, the drug should be administered on the first day only.
Novartis has launched Piqray at a wholesale acquisition cost (WAC) of $15,500 per month.