Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010.
The extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing and controls (CMC) section of the NDA as a major amendment to the NDA. The new action date will give the agency additional time to review the information submitted for this complex synthetic process.
In addition to the U.S. FDA priority review, eribulin is currently under active regulatory review in Japan, the European Union (EU), Switzerland and Singapore.
Eisai defines oncology as a therapeutic area of focus and is committed to developing novel anti-cancer agents and treatments for supportive care. With these efforts, Eisai seeks to further address the diversified needs of patients and families affected by cancer, and their healthcare professionals.
Study shows AI can predict prognosis in triple-negative breast cancer