09-20-2013, 06:17 AM
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#1
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Senior Member
Join Date: Mar 2006
Posts: 4,778
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TDM1 wins approval in Japan, recommended for approval in EU YEAH!
http://www.reuters.com/article/2013/...98J0DX20130920
LONDON | Fri Sep 20, 2013 8:28am EDT
(Reuters) - Roche's new breast cancer drug Kadcyla was approved in Japan on Friday and recommended for approval in Europe, building on February's U.S. green light for the product.
Kadcyla is designed for patients with late-stage disease whose cancer cells contain increased amounts of a protein known as HER2.
It works by attaching Herceptin to a drug called DM1, developed by ImmunoGen, which interferes with cancer cell growth.
Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
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