NICE issues guidance for Herceptin, Glivec

The U.K.'s NICE issued final guidance for two cancer drugs that is in line with previously issued final appraisal determinations, including a recommendation for Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) 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 Herceptin in the indication, irrespective of IHC score. Herceptin is approved for patients that are IHC2 or IHC3 positive. NICE said gastric cancer affects 8,200 patients in the U.K. each year -- of whom about 500 would be eligible to receive Herceptin under NICE's recommendation. ...