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