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Novartis gains FDA approval for a new indication for Kisqali

Novartis has received the Food and Drug Administration’s blessing for Kisqali (ribociclib) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Kisqali is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women in the United States, and also is indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women.

Kisqali was initially approved by the FDA in March 2017 and by the European Commission in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial.

FDA reviewed this supplemental New Drug Application, or sNDA, under its Real-Time Oncology Review and Assessment Aid pilot programs, and approved the application in less than one month after submission.

"Compelling data for Kisqali have led to the broadest first-line indications of any CDK4/6 inhibitor,” Novartis Oncology CEO Liz Barrett said. "With this new approval Kisqali has the potential to help even more people in the United States live a longer life without progression of disease from this incurable form of breast cancer."

"Premenopausal women diagnosed with advanced breast cancer often face unique social challenges and a poorer prognosis. For the first time in nearly 20 years, we have results from a dedicated clinical trial among these women," Young Survival Coalition's CEO Jennifer Merschdorf, said. "With this approval, some younger women now have a new therapy indicated specifically for them that may help extend their lives without progression of disease."
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