The European Union’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the use of Roche's 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. The 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.”

Perjeta is a personalised medicine that targets the HER2 receptor, a protein found in high quantities on the outside of cells in HER2-positive cancers. Perjeta is believed to work in a way that is complementary to Herceptin, as the two medicines target different regions on the HER2 receptor.

In June 2012, the US Food and Drug Administration (FDA) approved Perjeta 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. On 12 December 2012, Genentech submitted a supplemental Biologics License Application (sBLA) to the FDA for inclusion of the updated overall survival results in the Perjeta label. Perjeta was approved by Swissmedic in August 2012 and in Mexico in September 2012 for the treatment of people with HER2-positive mBC who have not received prior therapy for their metastatic disease.

Perjeta is designed specifically to prevent the HER2 receptor from pairing (dimerising) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The combination of Perjeta, Herceptin and chemotherapy is thought to provide a more comprehensive blockade of HER signalling pathways.