IS9-3 - Treatment of Metastatic or Recurrent Breast Cancer in Japan: Clinical Practice, Clinical Research and Regulatory Science

Abstract

Both breast cancer incidence and death rate are still increasing in Japan. Treatment options including chemotherapy, hormone therapy and targeting agents for metastatic/recurrent breast cancer is rapidly expanding and we can achieve “State of the Art” treatment for Japanese breast cancer patients on the basis of treatment guideline by the Japanese Breast Cancer Society. However, different from the US, most of the Japanese breast cancer patients are treated by surgical oncologist and most clinical trials are mainly conducted by surgeons. In addition, there is only limited number of clinical trial groups that can achieve large-scale phase III post-marketing trials focusing breast cancer. Although approval of new drugs in Japan have lagged behind those in the US and Europe for many years, the situation has been improved with reducing lag time. There is still some discrepancy for approval of new drugs for breast cancer between Japanese Pharmaceuticals and Medical Device Agency (PMDA) and the US Food and Drug Administration (FDA). PMDA approved use of bevacizumab in combined with paclitaxel in the treatment of metastatic/recurrent breast cancer based on results of pivotal trials conducted outside Japan, although FDA removed the indication for treatment of metastatic breast cancer of the AvastinTM label.