Novartis' PI3K inhibitor Piqray authorised by FDA for certain patients with advanced breast cancer

Novartis on Friday announced the approval of Piqray (alpelisib) for use in combination with AstraZeneca's endocrine therapy Faslodex (fulvestrant) to treat postmenopausal women, as well as men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. "Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer," commented Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

Approval was backed by data from the Phase III SOLAR-1 trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation, whose disease had progressed while on or after receiving an aromatase inhibitor. In study results unveiled last October, the addition of Piqray to Faslodex cut the risk of death or disease progression by 35 percent, compared with Faslodex alone. Novartis noted that Piqray also provided consistent progression-free survival results across pre-specified subgroups, including among patients previously treated with a CDK4/6 inhibitor.

The FDA noted that the therapy, which was assessed under a priority review, is the first novel drug authorised under its Real-Time Oncology Review pilot programme. Novartis' CDK4/6 inhibitor Kisqali (ribociclib) had its label expanded under the same programme last year for new uses in HR-positive, HER2-negative advanced or metastatic breast cancer.

The FDA on Friday also disclosed that Qiagen's therascreen PIK3CA RGQ PCR Kit was approved as a companion diagnostic test for detecting the PIK3CA mutation.

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