FDA Grants Priority Review to Supplemental New Drug Application for Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer


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Janssen Research & Development, LLC, announced that the FDA has granted Priority Review to the supplemental New Drug Application (sNDA) for abiraterone acetate (Zytiga) 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.

Priority Review Designation

The FDA grants Priority Review to medicines that may offer major advances in treatment, or provide a treatment option where no adequate therapy exists. Under the Prescription Drug User Fee Act, the FDA will aim to conclude its review within 6 months of the sNDA submission. The sNDA for abiraterone was submitted in June.

“We believe that men with metastatic castration-resistant prostate cancer 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 L. Meyers, MD, PhD, Vice President, Compound Development Team Leader, Zytiga.

About Abiraterone

Abiraterone is an oral agent that inhibits CYP17, an enzyme expressed in testicular, adrenal, and prostatic tumor tissue that is required for androgen biosynthesis.

The abiraterone sNDA submission is based on the efficacy and safety results of an international phase III, randomized, double-blind, placebo-controlled clinical study that evaluated abiraterone plus prednisone compared to placebo plus prednisone in 1,088 asymptomatic or mildly symptomatic men with metastatic castration-resistant prostate cancer who had not received chemotherapy. Data from this study were presented at the 48th ASCO Annual Meeting in June.

Abiraterone in combination with prednisone was approved by the FDA in April 2011 for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

The most common adverse reactions (greater than or equal to 5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures, and upper respiratory tract infection. ■



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