Kisqali regulatory update

FDA approved an NDA from Novartis for Kisqali ribociclib in combination with an aromatase inhibitor as first-line treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. On March 13, the pharma said the cyclin dependent kinase 4 (CDK4) and CDK6 inhibitor will be available in retail and specialty pharmacies, with shipments beginning "as early as tomorrow." Novartis also said the treatment will be available in 3 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 a 200 mg dose will cost $4,380; the recommended starting dose is 600 mg. In comparison, competing CDK4/6 inhibitor Ibrance palbociclib from Pfizer Inc. (NYSE:PFE, New York, N.Y.) has a WAC of $10,963.05 for a 28-day treatment cycle of the 75, 100 and 125 mg doses; the recommended starting dose is 125 mg. Novartis said its goal was to price Kisqali at about 18-20% aggregate discount to Ibrance.

The approval was based on data from the international MONALEESA-2 trial, which was stopped early after an interim analysis found that Kisqali met the primary endpoint of improving progression-free survival (PFS) (see BioCentury, May 23, 2016 & Oct. 17, 2016). The label recommends monitoring for QT elongation and hepatobiliary toxicity. Kisqali has breakthrough therapy status...