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Abiraterone Approaches EU Approval for Newly Diagnosed Hormone-Sensitive Prostate Cancer

Jason Harris
Published: Monday, Oct 16, 2017

Karim Fizazi, MD, PhD
Karim Fizazi, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the existing marketing authorization for abiraterone acetate (Zytiga) to include use in combination with prednisone/prednisolone and androgen deprivation therapy (ADT) in men with newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer.

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.

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