The Pharmaceutical Journal
Vol 276 No 7389 p222
25 February 2006

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MA for Herceptin submitted

Roche announced this week that it has submitted a marketing authorisation application to the European Medicines Agency for Herceptin (trastuzumab) as adjuvant treatment for early stage HER2-positive breast cancer.

The National Institute for Health and Clinical Excellence agreed last year (PJ, 12 November 2005, p600) that it would fast track its assessment of Herceptin under a new appraisal system that allows guidance to be issued as soon as eight weeks after a drug receives its marketing authorisation.