Novartis Kisqali receives FDA approval for HR+ / HER2- metastatic breast cancer


Swiss-based healthcare company Novartis has received approval from the US Food and Drug Administration (FDA) for its Kisqali (ribociclib) in combination with an aromatase inhibitor as the first-line treatment of advanced or metastatic breast cancer.

Formerly known as LEE011, Novartis’s Kisqali combination is an endocrine-based therapy used to treat post-menopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+ / HER2-) metastatic breast cancer.

Kisqali is a CDK4/6 inhibitor that has revealed considerable improvement in progression-free survival (PFS) compared to letrozole alone at the first pre-planned interim analysis.

Novartis oncology chief executive officer Bruno Strigini said: “Kisqali is emblematic of the innovation that Novartis continues to bring forward for people with HR+ / HER2- metastatic breast cancer.

"We at Novartis are proud of the comprehensive clinical programme for Kisqali that has led to today’s approval and the new hope this medicine represents for patients and their families."

“We at Novartis are proud of the comprehensive clinical programme for Kisqali that has led to today’s approval and the new hope this medicine represents for patients and their families.”

The US FDA has approved the Novartis treatment based on the superior efficacy and demonstrated safety of Kisqali plus letrozole, as opposed to letrozole alone, in the Phase III MONALEESA-2 trial.

Conducted on 668 postmenopausal women with HR+ / HER2- advanced or metastatic breast cancer who received no prior systemic therapy, the Phase III MONALEESA-2 trial revealed that Kisqali, in combination with letrozole, reduced the risk of progression or death by 44% over the use of letrozole alone.

Taken with or without food, the once-daily oral dose of 600mg comprises three 200mg tablets and is to be used by the patients for three weeks, followed by one week of treatment.