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Novartis Breast Cancer Drug Approved By Breakthrough FDA Novartis Breast Cancer Drug Approved By Breakthrough FDA

Novartis today announced that Kisqali (ribociclib) has received the FDA's breakthrough therapy designation for the treatment of pre-menopausal and perimenopausal hormone receptors in combination with tamoxifen or aromatase inhibitors Positive, human epidermal growth factor receptor 2 negative (HR + / HER2-) women with advanced or metastatic breast cancer.

Premenopausal breast cancer is a more biologically unique and invasive disease than postmenopausal breast cancer and is the leading cause of cancer death among women aged 20-59 years.

Kisqali, a selective inhibitor of cyclin-dependent kinases, helps slow cancer progression by inhibiting both proteins, cyclin-dependent kinases 4 and 6 (CDK4 / 6). When these proteins are over-activated, cancer cells can grow and divide too fast. While targeting CDK4 / 6 with greater precision prevents uncontrolled replication of cancer cells. Kisqali was approved last year as an initial endocrine regimen in combination with aromatase inhibitors for postmenopausal hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR + / HER2-) advanced or metastatic breasts Female cancer patients. Currently, Kisqali has been used in 45 countries worldwide, including the United States and EU member states, but it has not yet been approved for pre-menopausal women.

The formula of Ribociclib
▲ The formula of Ribociclib

This breakthrough approach is based on the positive results of Phase 3 clinical trial MONALEESA-7 and demonstrates that Kisqali in combination with tamoxifen or aromatase inhibitors significantly prolongs progression-free survival (PFS) compared with endocrine therapy alone PFS 23.8 months, 95% CI: 19.2 months - less than; 13.0 months, 95% CI: 11.0-16.4 months; HR = 0.553; 95% CI: 0.441-0.694; p

MONALEESA-7 is the first phase 3 clinical trial exclusively dedicated to assessing the use of CDK4 / 6 inhibitors in premenopausal women with HR + / HER2- advanced breast cancer. In the median PFS subgroup analysis of endocrine drugs, the median PFS for Kisqali in combination with tamoxifen and goserelin was 22.1 months compared with 11.0 months for tamoxifen and goserelin groups; Kisqali The median PFS for the combination of aromatase inhibitors and goserelin was 27.5 months, compared with 13.8 months for aromatase inhibitors and goserelin.

"This groundbreaking treatment identifies the importance of the MONALEESA-7 data released at SABCS last month and the commitment it has delivered." Dr. Samit Hirawat, director of global drug development at Novartis Cancer Corporation, said: "Young women tend to have Different treatment goals and needs are important for oncologists to provide an effective and well-studied treatment regimen for their particular illness and we look forward to working with the FDA to make this combination therapy suitable for HR + / HER2- Advanced breast cancer. "

We look forward to this new breast cancer can expand the indications as soon as possible, for the majority of women with advanced breast cancer rehabilitation.
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