Herceptin trastuzumab regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending against the use of Roche's Herceptin trastuzumab 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 - its approved indication. Comments are due by July 27, with a second appraisal meeting scheduled for August 11.

According to GSK, Herceptin plus cisplatin and capecitabine produced a mean overall survival gain of 4.8 months compared to epirubicin plus cisplatin and capecitabine. The company's models also suggest Herceptin plus cisplatin and 5-fluorouracil produced a mean survival gain of 4.3 months compared to epirubicin with cisplatin and 5-fluorouracil. ...