FDA Grants Priority Review to Palbociclib as First-Line Therapy in Combination With Letrozole in Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Pfizer’s New Drug Application for palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor–positive, HER2-negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, phase II trial comparing palbociclib plus letrozole vs letrozole alone in this population of patients.
The FDA’s Priority Review status accelerates the review time from 10 months to a goal of 6 months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act goal date for a decision by the FDA is April 13, 2015.
Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic estrogen receptor–positive, HER2-negative breast cancer.
Pfizer recently announced the initiation of a multicenter, open-label expanded access program in the United States for palbociclib. Through the program, palbociclib is available to postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer who are eligible for letrozole therapy and for whom enrolling in other palbociclib clinical trials is not an option.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
