Pfizer Gets FDA OK for Small-Molecule Breast Cancer Drug
Pfizer has received US Food and Drug Administration approval for Ibrance (palbociclib), a small molecule to treat advanced (metastatic) breast cancer.
Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. Ibrance is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women. The FDA granted Ibrance breakthrough therapy designation, priority review, and accelerated review. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory Phase III trial, PALOMA-2, is fully enrolled.