Women with advanced estrogen receptor-positive (ER-positive) breast cancer now have a new treatment option at their disposal. The FDA recently approved a drug called palbociclib (Ibrance®) as a frontline treatment for women with ER-positive, HER2-negative metastatic breast cancer.
Palbociclib granted accelerated approval
Research investigating palbociclib has delivered promising results. Based on the phase 2 results of the PALOMA-1 clinical trial, palbociclib was granted “breakthrough therapy designation” by the FDA. On February 3, the FDA announced it had approved palbociclib through an accelerated process because clinical data showed clear potential for clinical benefit to patients.