Double win for Novartis

PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of HR+/HER2 breast cancer patients have this mutation, which is associated with tumour growth, resistance to endocrine treatment and a poor overall prognosis. Piqray targets the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer. In clinical trials, Piqray plus fulvestrant nearly doubled median progression-free survival compared to fulvestrant alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation. Overall response rate was more than doubled when Piqray was added to fulvestrant in patients with a PIK3CA mutation.

"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, 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."

Earlier the same day, Novartis had its top price gene therapy Zolgensma approved. While not as pricey as Zolgensma, Piqray will be sold in the US for around US$200,000 a year, Endpoint News reports. Concurrent with the approval of Piqray, the therascreen PIK3CA companion diagnostic test from QIAGEN was also approved by the FDA.

“We are very pleased to launch this innovative companion diagnostic in tandem with our partners at Novartis. This milestone further underscores our commitment to support patients with breast cancer,” commented Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “We are convinced that our new therascreen PIK3CA Kit, which expands our market-leading therascreen portfolio of companion diagnostics, and the approval of PIQRAY together provide a valuable treatment option for those searching for new ways to combat advanced breast cancer.”