Roche’s perjeta receives recommendation for approval in EU

Hannah Blake

pharmaphorum

The European Union’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion to Roche’s Perjeta (pertuzumab) for use 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 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. 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.”

Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development.

The CHMP opinion is based on positive overall survival and progression-free survival data from the phase 3 clinical study, CLEOPATRA. Updated overall survival results showed the risk of death was reduced by 34 percent for people who received the Perjeta combination. These results were recently reported at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium.

Perjeta was approved in the US by the FDA in June 2012, for use in combination with herceptin and docetaxel chemotherapy for the treatment of people with HER2-positive mBC, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease, based on the results of the CLEOPATRA study.

In August 2012, Perjeta was approved by Swissmedic and in September 2012 it was approved in Mexico. Both approvals were for the treatment of people with HER2-positive mBC who have not received prior therapy for their metastatic disease.

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