Novartis Gets FDA Breakthrough Therapy Status For Breast Cancer Drug

Novartis had been granted Breakthrough Therapy designation by the US Food and Drug Administration for ribociclib, in combination with letrozole, for treating hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced or metastatic breast cancer. Ribociclib is a selective cyclin-dependent kinase (CDK4/6) inhibitor.

Ribociclib represents a class of drugs that help slow the progression of cancer by inhibiting CDK4/6 proteins. These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly. The drug has been studied in non-clinical models and is currently being evaluated in combination with additional endocrine agents as part a clinical trial program. Ribociclib is not approved for any indication in any market at this time.

Source: Novartis

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