The FDA has granted a priority review to Pfizer's new drug application (NDA) for palbociclib as a first-line therapy in combination with letrozole as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease, the firm said on 13 October.
The agency is expected to make a decision by 13 April 2015, the experimental medicine's Prescription Drug User Fee Act action date.
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