ZURICH -- Roche Holding AG (ROG.VX) Friday said the European
Union's Committee for Medicinal Products for Human Use has given a
positive opinion for the use of Perjeta in combination with
Herceptin and docetaxel in patients with HER2-positive metastatic
or locally recurrent unresectable breast cancer.
MAIN FACTS:
- 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).1
- "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, 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."
-Zurich Bureau, Dow Jones Newswires, +41 43 443 80 47;
zurichdjnews@dowjones.com
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