14 February 2018 - - Beerse, Belgium-based Johnson and Johnson (NYSE: JNJ) subsidiary, Janssen-Cilag International NV has submitted a marketing authorisation application to the European Medicines Agency for apalutamide, an investigational, next generation oral androgen receptor inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC), the company said.
The submission is based on data from the SPARTAN Phase 3 clinical trial which assessed the safety and efficacy of apalutamide versus placebo in men with nmCRPC who have a rapidly rising prostate specific antigen level, despite receiving continuous androgen deprivation therapy.
The SPARTAN clinical trial showed a 72% reduction in risk of distant metastasis or death compared to placebo in combination with ADT and improved median metastasis-free survival by over two years (difference of 24.3 months) in patients with nmCRPC whose PSA is rapidly rising.
SPARTAN, a Phase 3, randomised, double-blind, placebo-controlled, multicenter study, enrolled 1,207 patients with non-metastatic castration-resistant prostate cancer and was conducted at 332 sites in 26 countries in North America, Europe, Asia-Pacific and Australia.
Apalutamide, an investigational, next-generation oral androgen receptor inhibitor that blocks the androgen signaling pathway in prostate cancer cells, inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.
The Janssen Pharmaceutical Companies of Johnson and Johnson (NYSE: JNJ) work to find new and better ways to prevent, intercept, treat, and cure disease.