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FDA expands J&J Zytiga combo's indication to include castration-sensitive prostate cancer

Published on 09/02/18 at 09:45am

Johnson & Johnson has announced that Zytiga (abiraterone acetate) in combination with prednisone has been awarded FDA approval in the treatment of metastatic high-risk castration-sensitive prostate cancer (CSPC).

The decision was based on data drawn from a large multinational Phase 3 trial which demonstrated that J&J’s combo treatment reduced risk of death from CSPC by 38% compared to placebo in metastatic, high-risk CSPC patients who had not received prior cytotoxic chemotherapy. In addition, the therapy also significantly delayed the time to initiation of chemotherapy for patients. The data were revealed at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

“Latitude was a large global trial which produced impressive and clinically significant results in overall survival,” commented Dr Karim Fizazi, Principal Investigator and Head of the Medical Oncology Department at Institute Gustave Roussy, France. “With today’s approval, abiraterone acetate plus prednisone could become a standard of care for patients with metastatic high-risk castration-sensitive prostate cancer.”

Just a few months prior to this approval in November, the combination of Zytiga and prednisone saw its indications expanded in Europe to include the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer.

Dr Andree Amelsberg, Vice President of Oncology Medical Affairs at Janssen Biotech, also remarked: “Today’s approval marks an important step in addressing the unmet needs of patients with metastatic high-risk castration-sensitive prostate cancer by providing an option that has demonstrated improvement in overall survival. This milestone is an exciting turning point for researchers and clinicians, and most importantly, for patients suffering from this disease and their families who now have an important additional therapeutic option.”

Matt Fellows

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