EC approves Novartis' Kisqali for breast cancer

The European Commission approved Kisqali ribociclib from Novartis AG (NYSE:NVS; SIX:NOVN) for use in combination with an aromatase inhibitor as first-line treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women. Novartis said it is in reimbursement discussions and hopes to provide patient access to Kisqali "as quickly as possible."

Kisqali's approval was based on data from the Phase III MONALEESA-2 trial, which was stopped early after an interim analysis showed that Kisqali plus letrozole met the primary endpoint of improving median progression-free survival (PFS) vs. letrozole alone (25.3 vs. 16 months, p<0.0001) (see BioCentury Extra, Oct. 10, 2016)...