Drugmaker Pfizer announced Aug. 21 that it is starting a new open-label expanded access program in the U.S. for its new medication called palbociclib. The drug will be available for post-menopausal women who have hormone receptor positive (ER+) human epidermal growth factor 2 (HER2-) negative advanced breast cancer.
Palbociclib is to be taken with letrozole, a non-steroidal aromatase inhibitor that's commonly given after surgery to treat hormonally-responsive breast cancer. Women who have not received previous systemic treatment for their disease are able to take this new drug.
According to Market Watch, the company announced it submitted a new drug application for palbociclib to the Food and Drug Administration on Aug. 18.
The FDA gave the drug the Breakthrough Therapy designation in April 2013, meaning that palbociclib will receive an expedited review for potential serious of life-threatening conditions it may cause. However, in order to receive this designation, there must be clinical evidence that the drug may significantly improve the health condition of the individual using it.
"Palbociclib is being evaluated as a potential new treatment for women with HR+, HER2- advanced breast cancer, who represent the largest subgroup of women with this disease," Dr. Mace Rothenberg, chief medical officer of Pfizer Oncology, said in a statement.
The oral drug was designed to prevent the growth of breast cancer tumors and encourage the growth of cancer-free cells.Whizzco