Novartis’s kinase inhibitor Piqray makes its way into Latin America

The National Health Surveillance Agency (ANVISA) this week granted Brazil market clearance to Switzerland-based Novartis’s oncology treatment Piqray (alpelisib), as GBI analysis reveals. The oral drug is developed to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. However, the agency is yet to publish indication details.

Some tumors can originate from unregulated activation of the phosphatidylinositol-3-kinase (PI3K) signaling pathway due to gain-of-function mutations in its gene. Piqray inhibits PI3K activity to prevent phosphorylation of its downstream targets, resulting in reduced tumor growth.

GBI analysis shows that ANVISA’s is the first approval obtained by Piqray in Latin America.


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