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FDA Approves Alpelisib for Breast Cancer

Jason M. Broderick @jasoncology
Published: Friday, May 24, 2019

The FDA has approved the PI3K inhibitor alpelisib (Piqray) for use in combination with fulvestrant as a treatment for postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

"For this approval, we employed some of our newer regulatory tools to streamline reviews without compromising the quality of our assessment. This drug is the first novel drug approved under the Real-Time Oncology Review pilot program. We also used the updated Assessment Aid, a multidisciplinary review template that helps focus our written review on critical thinking and consistency and reduces time spent on administrative tasks," added Pazdur.


In SOLAR-1, 572 postmenopausal women or men with HR-positive, HER2-negative advanced breast cancer were randomized to oral alpelisib (300 mg/day) or placebo plus intramuscular fulvestrant (500 mg every 28 days and on days 1 and 15 of treatment cycle 1). A total of 341 patients had PIK3CA mutations when tumor tissue was tested, with 169 receiving the alpelisib combination and 172 taking fulvestrant alone.

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Online CME Activities
TitleExpiration DateCME Credits
Enduring CME activity from the School of Breast Oncology®: 2018 Mid-Year Video UpdateSep 28, 20192.0
Community Practice Connections™: 2nd Annual School of Nursing Oncology™Sep 28, 20191.5
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