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EU Approves Abiraterone for Newly Diagnosed Hormone-Sensitive Prostate Cancer

Jason Harris
Published: Tuesday, Nov 21, 2017

Karim Fizazi, MD, PhD

Karim Fizazi, MD, PhD
The European Commission (EC) has approved abiraterone acetate (Zytiga) in combination with prednisone/prednisolone for the treatment of adult men with newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

“This EC approval is a major step forward for men living with prostate cancer across Europe and offers patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer a new treatment option,” Ivo Winiger-Candolfi, MD, oncology solid tumor therapy area lead, Janssen Europe, Middle East and Africa, said in a statement. “We are encouraged by the data we have seen to date and remain committed to transforming outcomes for prostate cancer patients.”


  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 L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med. 10.1056/NEJMoa1704174.

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