The approval was based on first-line results of Phase III Monaleesa-2 trial that met its primary endpoint early, showing statistically significant improvement in progression-free survival (PFS) compared against letrozole alone at the first pre-planned interim analysis.
Kisqali has been assessed and approved under the FDA breakthrough therapy designation and priority review programs.
In the trial, the company recruited 668 postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who secured no prior systemic therapy for their advanced breast cancer.
According to Novartis, the trial demonstrated that Kisqali plus an aromatase inhibitor letrozole reduced the risk of progression or death by 44% over letrozole alone.
As part of research collaboration with Astex Pharmaceuticals, the Novartis Institutes for BioMedical Research (NIBR) has developed Kisqali.
Novartis Oncology CEO 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 program for Kisqali that has led to today's approval and the new hope this medicine represents for patients and their families."
Image: The FDA has approved Kisqali in combination with an aromatase inhibitor to treat metastatic breast cancer. Photo: courtesy of Novartis.