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View Full Version : TDM1 wins approval in Japan, recommended for approval in EU YEAH!


Lani
09-20-2013, 06:17 AM
http://www.reuters.com/article/2013/09/20/us-medicines-europe-idUSBRE98J0DX20130920

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.

karen z
09-20-2013, 02:33 PM
great news.

michka
09-23-2013, 02:42 AM
Thanks for the info Lani. I was loosing hope. The last I heard from my oncs is that TDM1/Kadcyla would not be available in France before beginning 2015. "Recommended for approval" is not approval and it then has to be approved by each country but I am happy to learn something is moving.