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.
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