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

pharmafile | May 28, 2019 | News story | Manufacturing and Production, Sales and Marketing Cancer, FDA, Novartis, Piqray, breast cancer, fulvestrant, pharma 

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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