The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (J&J) drug Zytiga (abiraterone acetate) in combination with prednisone as an effective treatment for metastatic high-risk castration-sensitive prostate cancer (CSPC).
The decision follows the success of a multinational Phase III trial dubbed ‘Latitude’. This found that J&J’s combination treatment decreased CSPC-related deaths by 38% compared to placebo. Additional data demonstrated that the treatment led to a marked delay in time to initiation of chemotherapy in patients.
1,199 patients took part in the study, none of whom had received prior cytotoxic chemotherapy. However, they did receive a gonadotropin-releasing hormone analogue, or had previously had bilateral orchiectomy. The study took place across 235 locations in 34 countries in Europe, South America and Asia-Pacific as well as Canada.
Institute Gustave Roussy’s head of Oncology Dr Karim Fizazi said the study “produced impressive and clinically significant results in overall survival”,
“With today’s approval, abiraterone acetate plus prednisone could become a standard of care for patients with metastatic high-risk castration-sensitive prostate cancer,” Fizazi added.
Zytiga was first approved in the US in April 2011 for treatment of late-stage prostate cancer. Since then, it has been approved in combination with prednisone or prednisolone in 105 countries.
In November 2017 the European Commission (EC) granted marketing authorisation for Zytiga’s combination with prednisone to extend to high-risk metastatic hormone-sensitive prostate cancer (HSPC). Similar submissions have been made in Japan, Mexico, Switzerland, Singapore, the Philippines and Canada.
Janssen Biotech ’s vice president of oncology Dr Andree Amelsberg said:
“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.”