Herceptin trastuzumab regulatory update
The U.K.'s NICE issued a final appraisal determination (FAD) recommending against Tyverb lapatinib from GlaxoSmithKline plc and Herceptin trastuzumab from the Genentech Inc. unit of Roche in combination with an aromatase inhibitor as a first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer. The decisions are in line with February draft guidance (see BioCentury, Feb. 20).
NICE already recommends Herceptin for HER2-positive breast cancer following surgery, chemotherapy and radiotherapy, for metastatic breast cancer with high levels of expression of HER2 and in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-positive, metastatic adenocarcinoma of the stomach or gastro-esophageal junction. ...