November 21, 2006
Product news from the 11/21/06 news brief
Takeda Pharmaceutical has discontinued of development of its investigational compound, TAK-128 to treat peripheral diabetic neuropathy. Phase II clinical studies of TAK-128 have been conducted in Japan, North America and Europe, and based on the thorough review of the clinical data obtained to date, Takeda and Mitsubishi Pharma concluded that TAK-128 does not show sufficient efficacy to support continuation of development activities, the companies said in a statement. Genentech said the FDA has approved its Herceptin (trastuzumab) breast cancer drug as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment - surgery with or without radiation therapy - with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease. Herceptin first received FDA approval in September 1998 for use in women with metastatic breast cancer. In this setting, it is indicated for treatment of patients both as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy.