Roche’s breast cancer treatment Perjeta receives recommendation for approval in EU Freitag, 14. Dezember 2012 - 14:08

Roche’s breast cancer treatment Perjeta receives recommendation for approval in EU

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the use of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable breast cancer (mBC). The recommendation supports an indication for people with this specific type of cancer who have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease.

The CHMP opinion is based on positive overall survival and progression-free survival data from the phase III CLEOPATRA study. Updated overall survival results recently reported at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium showed the risk of death was reduced by 34 percent for people who received the Perjeta combination (HR=0.66; p=0.0008). “The CHMP positive opinion for Perjeta brings us a significant step closer to the approval of a new personalised medicine for people with this aggressive form of breast cancer,” said Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Perjeta complements Herceptin in attacking HER2-positive tumours and we believe Perjeta will transform the way people with HER2-positive metastatic breast cancer are treated.” more

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