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news.Novartis has secured approval from the US Food and Drug Administration (FDA) for its breast cancer drug combo Piqray (alpelisib, formerly BYL719) plus fulvestrant.
Image: Novartis has secured FDA nod for breast cancer drug combo Piqray plus fulvestrant. Photo: courtesy of Novartis AG.
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The FDA has approved Piqray kinase inhibitor in combination with fulvestrant to treat postmenopausal women, and men with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after endocrine-based regimen.
The approval was based on data from the phase III Solar-1 study, which demonstrated Piqray plus fulvestrant nearly doubled median progression-free survival (PFS) compared against fulvestrant alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation.
According to the company, Piqray offered consistent PFS results across pre-specified subgroups including among patients previously treated with a CDK4/6 inhibitor and overall response rate (ORR) was more than doubled when Piqray was added to fulvestrant in patients with a PIK3CA mutation.
Solar-1 is a global, phase 111 randomized, double-blind and placebo-controlled study designed to assess Piqray in combination with fulvestrant for postmenopausal women, and men, with PIK3CA-mutated HR+/HER2- advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor.
The company has randomized 572 patients in the trial, and patients have been allocated based on central tumor tissue assessment to either a PIK3CA-mutated cohort or a PIK3CA non-mutated cohort.
The trial’s primary endpoint is local investigator evaluated PFS using RECIST 1.1 for patients with a PIK3CA mutation, while major secondary endpoint is overall survival and additional secondary endpoints are overall response rate, clinical benefit rate, health-related quality of life, efficacy in PIK3CA non-mutated cohort, safety and tolerability.
Novartis Oncology CEO Dr Susanne Schaffert said: “The FDA approval of Piqray, which was discovered at the Novartis Institutes for BioMedical Research, marks the first ever treatment specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation.
“We are grateful to our researchers’ bold and unrelenting pursuit of a first-in-class treatment for this incurable disease, and to the patients, investigators and administrators who participated in the clinical trials leading to this remarkable milestone.”
