Pfizer has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for palbociclib for the treatment of estrogen receptor-positive and human epidermal growth factor 2-negative advanced breast cancer in post-menopausal women.
Palbociclib is an orally administered cyclin-dependent kinases 4 and 6 (CDK4/CDK6) selective inhibitor to be used in conjunction with letrozole, an aromatase inhibitor.
Approval of the new drug application would be based on the phase 2 PALOMA-1 study, a randomized trial that compared palbociclib plus letrozole with letrozole alone. The study found that progression-free survival was 20.2 months in the palbociclib plus letrozole group and 10.2 months in the letrozole alone group, meaning palbociclib reduces the risk of disease progression by 51%. Overall survival was not significantly extended in the palbociclib group. Common adverse effects were bone marrow suppression and fatigue.
Palbociclib is currently being tested in two phase 3 studies. In the PALOMA-2 study, palbociclib is being studied in combination with letrozole for the treatment of advanced metastatic breast cancer. The drug is also being studied with fulvestrant in the PALOMA-3 study for the treatment of metastatic breast cancer.
US-based pharmaceutical company Pfizer has submitted a new drug application (NDA) for palbociclib to the US Food and Drug Administration (FDA).
The company is seeking approval for palbociclib, in combination with letrozole, to treat post-menopausal women with estrogen receptor positive (ER+) and human epidermal growth factor receptor two negative (HER2-) advanced breast cancer.
Pfizer Oncology president Garry Nicholson said: “Today’s submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer.”