The UK’s drug watchdog, the National Institute for Health and Clinical Excellence (NICE), this week delivery mixed news for Swiss drug majors Roche (ROG: VX) and Novartis (NOVN: VX), recommending the former’s Herceptin (trastuzumab) for the treatment of metastatic gastric cancer, but rejecting a higher dosage for the latter’s Glivec (imatinib) for GISTs.
The Roche announcement is a reversal of a previous decision not to permit National Health Service use of the drug in this indication (The Pharma Letter July 7), and is the result of the company providing additional data on efficacy that swayed the agency. Herceptin is already cleared for NHS use in the treatment of HER2+ metastatic breast cancer
In its final guidance, the NICE has recommended trastuzumab, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of people with HER2-positive, metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior treatment for their metastatic disease and whose tumours express high levels of HER2 as defined by a positive immunohistochemistry score of 3 (IHC3 positive).
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