Roche gets approval in Japan for Herceptin

Japanese health authorities have granted approval to Roche's metastaticbreast cancer drug Herceptin (trastuzumab), with the company noting that the regulatory go-ahead was primarily based on data from international pivotal trials. In Japan, about 34,000 women are newly diagnosed with breast cancer each year, and approximately one in five with metastatic breast cancer will be HER2-positive. Herceptin works by targeting the overactivity of the HER2 gene, which is associated with aggressive cancer cell growth.

Herceptin, which was discovered and developed by Genentech, was approved by the US Food and Drug Administration in September 1998. The drug is now available in over 60 countries.