Pfizer's palbociclib gets breakthrough designation
Pfizer Inc. (NYSE:PFE) said FDA granted breakthrough drug designation to palbociclib ( PD-0332991) to treat breast cancer. A spokesperson for the pharma said the oral small molecule cyclin dependent kinase 4 (CDK4) and CDK6 inhibitor received the designation for the broader indication, but said the designation was based on data from a Phase II trial of palbociclib in postmenopausal women with estrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer. The compound is in the Phase III Study 1008 in combination with Femara letrozole from Novartis AG (NYSE:NVS; SIX:NOVN) as first-line treatment for the indication. Pfizer has rights to palbociclib from Onyx Pharmaceuticals Inc. (NASDAQ:ONXX), which was up $4.19 to $94.36 on Wednesday. ...