Advanced breast cancer drug receives US marketing approval


Astex and Novartis' Kisqali receives FDA approval as a first-line treatment for HR+/HER2- advanced breast cancer with an aromatase inhibitor

Novartis has received FDA marketing approval for Kisqali (ribociclib) plus an aromatase inhibitor, as a first-line treatment in post-menopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

The company is the long-standing pharmaceutical collaborator of Astex Pharmaceuticals, a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system.

The partnership was struck to discover cell cycle inhibitors which represented a novel class of compounds that target the mechanisms of cell division to prevent or interfere with cancer growth.

The combination of Kisqali plus letrozole reduced the risk of disease progression or death by 44%.

Astex scientists at the company’s research laboratories in Cambridge (UK) solved the crystal structure of the key cancer target protein CDK4.

Working with Novartis at the Novartis Institutes for BioMedical Research, Astex applied its structure-based drug discovery technology to discover Kisqali, then known as LEE011.

Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drug that helps slow the progression of cancer by inhibiting two proteins (CDK4 and CDK6) which, if over-activated, can enable cancer cells to grow and divide quickly.

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In trials, the combination of Kisqali plus letrozole reduced the risk of disease progression or death by 44% compared to letrozole alone. Patients who took Kisqali plus letrozole saw their tumour size shrink by at least 30%.