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FDA Approval Sought for Abiraterone Acetate for Early-Stage Metastatic Prostate Cancer

Silas Inman @silasinman
Published: Friday, Sep 15, 2017

Dr Craig Tendler
Craig Tendler, MD
A supplemental new drug application has been submitted for abiraterone acetate (Zytiga) in combination with prednisone and androgen deprivation therapy (ADT) for high-risk patients with metastatic hormone-naïve prostate cancer (HNPC) or newly-diagnosed metastatic hormone-sensitive prostate cancer (HSPC), according to a statement from the company developing therapy, Janssen Biotech.

Abiraterone acetate was first approved in 2011 in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer following chemotherapy. It has since gained approval earlier in the treatment paradigm for use prior to chemotherapy.
References
  1. Fizazi K, Tran N, Fein LE, et al. the LATITUDE investigators. LATITUDE: A phase 3 double-blind, randomized trial of androgen deprivation therapy (ADT) with abiraterone acetate (AA) plus prednisone (P) or placebos (PBOs) in newly diagnosed high-risk metastatic hormone-naïve prostate cancer (mHNPC) patients (pts). J Clin Oncol. 2017;35 (suppl; abstr LBA3).
  2. Fizazi K, Tran N, Fein LE, et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017;377:352-360.
  3. Chi K, Protheroe A, Rodrigues Antolin A, et al. Benefits of Abiraterone Acetate Plus Prednisone (AA+P) When Added to Androgen Deprivation Therapy (ADT) in LATITUDE on Patient (Pt) Reported Outcomes (PRO). Presented at: 2017 ESMO Congress; Madrid, Spain; September 8-12, 2017. Abstract 783O.

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