Posted by Michael Wonder on 18 Jul 2018
Novartis Kisqali now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for pre-menopausal women; and as initial therapy with fulvestrant in postmenopausal women
18 July 2018 - Kisqali is now the only CDK4/6 inhibitor indicated in combination with an aromatase inhibitor as first-line treatment for pre-, peri- or post-menopausal women with HR+/HER2- advanced breast cancer in the US.
Novartis today announced a new approval for Kisqali (ribociclib) from the US FDA 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 post-menopausal women in the US, and also is indicated for use in combination with fulvestrant as both first- or second-line therapy in post-menopausal women.
FDA reviewed this supplemental new drug application under its real-time oncology review and assessment aid pilot programs and approved the application in less than one month after submission.
