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Source: Media Outreach

Piqray (alpelisib) is the only treatment approved specifically to address PIK3CA mutation
The approval was based on SOLAR-1 Phase III trial showing Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. 5.7 months) in HR+/HER2- advanced breast cancer patients with PIK3CA mutation, compared to fulvestrant alone.
Approximately 30-40% of those with HR+/HER2- subtype have a PIK3CA mutation, which is associated with a poor prognosis. In Singapore, the incidence of point mutations in PIK3CA, are amongst the most frequently reported to date for any gene in breast cancer.
SINGAPORE – Media OutReach – 1 March 2021 – Novartis announced the Health Sciences Authority (HSA) has approved* Piqray®, an α-specific class I phosphatidylinositol-3-kinase (PIK3CA) inhibitor, 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). “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.”

HSA approval is based on results of the Phase III trial, SOLAR-1, that showed Piqray plus fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation (median PFS 11.0 months vs 5.7 months; Hazard Ratio (HR)=0.65, 95% CI: 0.50-0.85; p – Published and distributed with permission of