The European Medicines Agency (EMA) has approved Roche's Perjeta (pertuzumab) for patients with previously untreated HER2-positive metastatic breast cancer (mBC). Perjeta is approved in combination with Herceptin (trastuzumab) and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
“The EU approval of Perjeta is the result of years of research into the HER2 pathway and we are excited to offer a new treatment option for people with this aggressive disease,” said Hal Barron, chief medical officer and head, global product development. “The combination of Perjeta, Herceptin and chemotherapy
is the first to significantly extend survival compared to the previous standard of care, Herceptin and chemotherapy alone."
The European approval comes after the phase III CLEOPATRA trial showed that the combination of Perjeta, Herceptin and chemotherapy provided patients with a median of 6.1 months longer without their disease worsening or death (progression-free survival, PFS) and provided a 34 percent reduction in the risk of death (overall survival) compared to Herceptin and chemotherapy alone.
Perjeta is an example of Roche’s Personalised Healthcare Approach as it targets the HER2 receptor, a protein found in high quantities on the outside of HER2-positive breast cancer cells. A diagnostic HER2 test is used to determine if a patient has HER2-positive breast cancer. Perjeta is believed to work in a way that is complementary to Herceptin, as the two medicines target different regions on the HER2 receptor.
Herceptin was the first monoclonal antibody developed for the treatment of HER2-positive breast cancer and has increased survival times for patients so that they are now the same as for patients with HER2-negative breast cancer. Before Herceptin treatment, shorter survival outcomes were expected for patients diagnosed with HER2-positive breast cancer, compared to patients with HER2-negative disease.1 In the study, Perjeta in combination with Herceptin and chemotherapy has shown the extension of survival times for patients with this aggressive disease even further than Herceptin.
Perjeta is now approved in the EU, the US, and Switzerland for the treatment of people with HER2- positive mBC who have not received prior therapy for their metastatic disease. Further country approvals are anticipated during 2013.
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.