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.
- 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).
- 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.
- 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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