FDA approves Novartis' Kisqali

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA approved Kisqali ribociclib in combination with an aromatase inhibitor as a first-line treatment for post-menopausal women with hormone receptor (HR) positive, HER2-negative advanced or metastatic breast cancer. The drug is under review in Europe in the same population; the pharma expects a decision next half.

On a conference call Monday, Head of Novartis US Oncology Bill Hinshaw said Kisqali will be available in retail and specialty pharmacies, with shipments beginning "as early as tomorrow." He said the treatment will be available in three doses, with a 600 mg dose carrying a wholesale acquisition cost (WAC) of $10,950 for the 28-day treatment cycle. A 400 mg dose will have a WAC of $8,760 per cycle, and 200 mg will cost $4,380...