FDA Approves Palbociclib for Metastatic Breast Cancer

Recently, FDA has granted an accelerated approval to Palbociclib as a treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer.

Inhibition of CDK 4/6 prevents DNA replication by prohibiting progression from G1 to S phase during cell division. Blocking this mechanism prevents tumor cell proliferation through control of the cell cycle. The rationale for the combination of an aromatase inhibitor with Palbociclib stemmed from early preclinical evidence suggesting that CDK 4/6 is more active in patients with ER-positive breast cancer.

Many anti-cancer drugs achieve the anti-tumor effect by acting on the epidermal growth factor receptor(EGFR), this receptor does not express in many breast cancer patients. However,the target of Palbociclib is estrogen receptor , which provides an expedited approval process for treatments that provide a substantial benefit over current options.At the same time, the addition of Palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer,