Novartis' Piqray approved for advanced breast cancer by HSA

Singapore’s Health Sciences Authority (HSA) has approved Piqray (alpelisib), an α-specific class I phosphatidylinositol-3-kinase (PIK3CA) inhibitor, from Swiss pharma giant Novartis (NOVN: VX) for the treatment of postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2-) negative, advanced breast cancer with a PIK3CA mutation in combination with fulvestrant after disease progression following an endocrine-based regimen.1

"Novartis has been researching the role of the PIK3CA mutation for more than 20 years and studying how to target this mutation in order to delay disease progression," said Itsaraet Gosriwatana, oncology general manager, Novartis (Singapore), adding: "The understanding of the PIK3CA status is crucial in equipping doctors to develop a better personalized treatment plan for patients. Today, we are pleased to be able to offer patients in Singapore with Piqray, an important new therapy for HR+/HER2- advanced breast cancer patients whose tumours have a PIK3CA mutation."

Piqray was approved for the same breast cancer indication in the USA in 2019 and in Europe the following year. For full-year 2020, it generated global sales of $320 million, a rise of 176% on the prior year. Baader Helvea’s Bruno Bulic previously gave the drug an 80% chance of peak sales reaching $1.9 billion per year.