Aromatase inhibitor (AI), Kisqali, a CDK4/6 inhibitor has received a specific indication from the Therapeutic Goods Administration (TGA) for use in pre-/peri-menopausal Australian women with advanced metastatic HR+/HER2-breast cancer.
This is said to be supported by significant overall survival data from the study, MONALEESA-7.
MONALEESA-7 has reportedly demonstrated Kisqali significantly prolongs life in pre-/peri-menopausal women (n=972):
- Kisqali plus endocrine therapy is said to have demonstrated a statistically significant improvement in overall survival rates vs placebo plus endocrine therapy.
- Kisqali plus endocrine therapy has also been shown to be associated with a 29 per cent relative reduction in risk of death vs placebo plus endocrine therapy.
“CDK4/6 inhibitors have changed the landscape of hormone receptor positive cancer, shifting the way we manage metastatic breast cancer and improving outcomes for patients,” explained Medical Oncologist, Peter MacCallum, Dr Richard de Boer.
“This is the first time a statistically significant improvement in overall survival has been observed with a CDK4/6 inhibitor in combination with endocrine therapy … and the first to evaluate this treatment exclusively in younger patients.
“Pre-menopausal women with metastatic breast cancer are at a significant period of their lives … This can lead to unique challenges in both their personal and professional lives,” he added.
An estimated 20,000 Australians will be reportedly diagnosed with breast cancer this year with approximately 20 per cent of Australian women diagnosed with breast cancer under the age of 50.