FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Novartis’ Kisqali Receives Breakthrough Therapy Designation

Jan. 9, 2018

The FDA issued a breakthrough therapy designation to Novartis’ Kisqali (ribociclib) for treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor as opposed to endocrine therapy alone.

The designation was based on results of Phase III trials that demonstrated superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal women who received no prior endocrine therapy for advanced disease.

This is the second breakthrough therapy designation granted to Kisqali for initial endocrine-based treatment in HR+/HER2- advanced or metastatic breast cancer.

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