Herceptin trastuzumab regulatory update

The U.K.'s NICE issued final guidance recommending Herceptin trastuzumab from Roche in a more limited population than its approved indication. Herceptin is recommended in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-positive, metastatic adenocarcinoma of the stomach or gastro-esophageal junction in patients who have not received prior treatment and whose tumors express high levels of HER2, as defined by a positive immunohistochemistry score of 3 (IHC3 positive). The final appraisal determination reversed a preliminary appraisal recommending against the humanized mAb against epidermal growth factor (EGF) receptor 2 (HER2; ErbB2; neu) in the indication, irrespective of IHC score (see BioCentury, Oct. 4). ...