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FDA approves Novartis Piqray - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer

Nachrichtenquelle: GlobeNewswire
24.05.2019, 22:12  |  948   |   |   

Novartis International AG / FDA approves Novartis Piqray - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

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  • Piqray (alpelisib, formerly BYL719) plus fulvestrant nearly doubled median PFS (11.0 vs 5.7 months) in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation compared to fulvestrant alone in the SOLAR-1 clinical trial[1],[2],[3],[4]
  • ~40% of HR+/HER2- advanced breast cancer patients may face worse disease prognosis due to presence of PIK3CA mutations in their tumors[5],[6],[7],[8],[9]
  • Piqray was the first new drug application approved under the FDA Oncology Center of Excellence Real-Time Oncology Review pilot program

The digital press release with multimedia content can be accessed here:


Basel, May 24, 2019 - Novartis today announced the US Food and Drug Administration (FDA) has approved Piqray (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of 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 an endocrine-based regimen[1].

PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation[8],[10]. PIK3CA mutations are associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis[11],[12]. Piqray targets the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer.

"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 proud to offer a new treatment option that specifically addresses the needs of the patients living with this mutation," said Susanne Schaffert, PhD, CEO, Novartis Oncology. "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."

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