FDA Grants Priority Review for Pfizer's HER2- Advanced Breast Cancer Treatment

Pfizer announced on Oct. 13, 2014 that it received FDA Priority Review for its new drug application for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The treatment, which is a combination of palbociclib and letrozole, is designed for women who have not received any prior systemic treatment for their advanced breast cancer.

Palbociclib is an oral-targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4/6 to regain cell cycle control and block tumor cell proliferation. Letrozole is a tablet used to treat the early stages of breast cancer in women who have experienced menopause and who have had treatments to remove the tumor; women who have had menopause and have taken tamoxifen for five years; or women who have had menopause and whose breast cancer has worsened while taking tamoxifen. Letrozole reduces the amount of estrogen produced by the body.

“If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the US who are living with metastatic breast cancer,” said Garry Nicholson, president, Pfizer Oncology, in a press release.

Source: Pfizer