November 10, 2016
Pfizer Inc. has announced that the European Commission (EC) has approved IBRANCE® (palbociclib) for treating women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The approval is for IBRANCE for using in combination with an aromatase inhibitor. It also covers the use of IBRANCE combining with fulvestrant in women who have received endocrine therapy previously.
IBRANCE is the first medicine to be approved in Europe that works by inhibiting cyclin-dependent kinases 4 and 6 (CDK 4/6). It is also the first medicine in nearly 10 years approved for treating women with this type of metastatic breast cancer in the first-line setting. Women with HR+/HER2- metastatic breast cancer represent about 60 percent of all metastatic breast cancer cases.
Andreas Penk, M.D., regional president, International Developed Markets, Pfizer Oncology, said: “Today’s approval of IBRANCE in the European Union (EU) brings an innovative and much-needed new treatment option to tens of thousands of women with HR+/HER2- metastatic breast cancer. With strong and consistent data in three pivotal clinical studies and rapid adoption as a standard of care in the U.S., IBRANCE represents a potential new benchmark for the treatment of HR+/HER2- metastatic breast cancer in Europe.”