EMA begins to review the non metastatic prostate cancer drug XTi

Source: Ding Xiangyuan March 22, 2018 according to pmlive's report on March 19, 2018, EU drug regulatory agencies have begun to review the application of Astaire and Pfizer's prostate cancer drug xtandi for non metastatic castration resistant prostate cancer (nmcrpc), which is an indication of fierce competition EMA started to evaluate the new indications of xtandi based on the results of the three-stage proser trial, which was conducted in patients with early prostate cancer who had not spread to other parts of the body Results reported in February showed that treatment with xtandi (enzalutamide) combined with antiandrogen reduced the risk of disease transmission or death by 71% compared with hormone therapy alone Although most early prostate cancer patients are effectively managed by hormone therapy, about 10-20% of prostate cancer cases are castrated resistant, and up to 16% of them have no evidence of cancer spread at the time of diagnosis Similar to its long-standing competitor, Johnson & Johnson's zytiga (abitrone acetate), xtandi is currently only suitable for men with advanced CRPC who have already spread and no longer respond to hormone therapy Therefore, if approved, the new indications will expand the treatment range of xtandi, so that it can be used for more patients Pfizer and Astaire are trying to increase their competitiveness by taking advantage of the increased patient population brought by the new indications, but erlada (apalutamine), a new drug of Johnson & Johnson, has been approved in the United States for the treatment of nmcrpc, and submitted an application for approval to Europe last month FDA approval is based on the Spartan study, which showed that erlada had a longer metastasis free survival than placebo for nmcrpc on the basis of hormone therapy The results of the Spartan and prosper trials have been described by oncologists as significant therapeutic advances, but it is not clear which drugs will win the market competition Erlada is the first approved drug, but xtandi will benefit from long-term use during CRPC treatment Analysts estimate that nmcrpc itself may represent a market of more than $1 billion, so the competition among products is fierce.