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FDA approves first therapy PIK3CA-mutated HR+/HER2- advanced breast cancer

Published on 28/05/19 at 10:27am

Novartis’ Piqray (alpelisib) has secured approval from the FDA in combination with AstraZeneca’s Faslodex (fulvestrant) for the treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer in both male patients and female postmenopausal patients.

The US regulator based its decision on Phase 3 data which demonstrated that the Piqray combo was almost twice as effective as fulvestrant monotherapy in improving progression-free survival, leading to median improvements of 11 months versus 5.7 months.

Additionally, the combo also improved overall response rate by more than double, showing a rate of 35.7% compared to 16.2% with fulvestrant alone.

"Today's approval is expected to change the way we practice medicine in advanced breast cancer. For the first time, physicians can test for PIK3CA biomarkers and develop a treatment plan based on the genomic profile of a patient's cancer," explained Dr Fabrice André, Research Director and head of INSERM Unit U981, Professor in the Department of Medical Oncology at Institut Gustave Roussy and global SOLAR-1 principal investigator. "In the SOLAR-1 Phase 3 trial, alpelisib plus fulvestrant nearly doubled median PFS and more than doubled overall response rate in patients with a PIK3CA mutation, offering them new hope for longer life without progression."

Dr Susanne Schaffert, CEO of Novartis Oncology, also remarked: "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. 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."

Matt Fellows

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