FDA approves Pfizer's Ibrance

FDA granted accelerated approval to Ibrance palbociclib ( PD-0332991) from Pfizer Inc. (NYSE:PFE) in combination with Femara letrozole as first-line treatment of postmenopausal women with estrogen receptor-positive, HER2-negative advanced breast cancer. Ibrance is an oral small molecule cyclin dependent kinase 4 ( CDK4) and CDK6 inhibitor.

Pfizer said Ibrance is the first CDK4/6 inhibitor FDA has approved. The agency granted approval under Priority Review well ahead of the April 13 PDUFA date. ...