FDA grants priority review of Zytiga sNDA

RARITAN, N.J. — The Food and Drug Administration has granted priority review to a supplemental new drug application for a drug developed by Janssen Research and Development.

Janssen Research and Development said the regulatory agency granted priority review for Zytiga (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer, who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy. Under the Prescription Drug User Fee Act, the FDA will aim to conclude its review within six months of the sNDA submission. The sNDA was submitted in June, the company said.

"We believe that men with mCRPC whose disease is asymptomatic or mildly symptomatic, for whom chemotherapy may not be immediately necessary, have limited treatment options and that this disease setting represents a critical unmet medical need," said Michael Meyers, VP and compound development team leader for Zytiga. "We are delighted the FDA has granted a priority review designation for our sNDA."


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