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Novartis announced that the European Commission (EC) has approved the combination of Piqisib with the fluorois group for the treatment of male patients with local lysatary advanced or metastatic breast cancer who are positive in hormone receptors and human epidermal growth factor receptor 2 negative (HR/HER2-), PIK3CA mutations, progression of disease after endocrine monodrug treatment, and postmenopausal female patients.
Piqray is the first and only approved drug for patients with advanced breast cancer with PIK3CA mutations.
334,000 people worldwide are diagnosed with advanced breast cancer each year, and about 40% of patients with HR/HER2-subtype have a PIK3CA mutation.
the approval was based on the positive results of the Phase III SOLAR-1 test, and the Piqray and Fluves group combinationneared the median progression-free survival (PFS) (5.7 and 11.0 months, respectively) and more than doubled the overall response rate compared to the fluvews group single use.
Photo Source: Novartis's official website Piqray is an inhibitor of phosplyinininol-3-kinase (PI3K), mainly for PI3K alpha (PIK3CA).
PIK3CA mutation causes THE ACTIVATION of PI3K alpha and Akt signals, stimulates tumor growth and is closely related to patient prognosis.
Photo Source: Novartis.com