Roche Media Release: CHMP grants positive opinion for Roche’s Kadcyla, the first antibody-drug conjugate for advanced HER2-positive breast cancer Freitag, 20. September 2013 - 17:56

CHMP grants positive opinion for Roche’s Kadcyla, the first antibody-drug conjugate for advanced HER2-positive breast cancer • Kadcyla helped extend the life expectancy of people with previously treated advanced disease to more than two and a half years overall in a Phase III clinical study • Kadcyla’s mode of action aims to preserve quality of life as it delivers chemotherapy directly to cancer cells, limiting damage to healthy tissues • European Commission decision is expected by the end of the year

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Kadcyla (trastuzumab emtansine or T-DM1) as a single agent, for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

“Kadcyla’s highly effective, targeted mode of action offers patients a chance to extend their lives with fewer of the side effects commonly experienced with chemotherapy,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “We hope that this new medicine is soon available to patients with metastatic breast cancer in Europe.” more

With best regards, Roche Group Media Relations

Roche Group Media Relations Grenzacherstrasse 124 4070 Basel, Switzerland

Phone: +41 61 688 88 88 Fax: +41 61 688 27 75 mailto:roche.mediarelations@roche.com www.roche.com