Swissmedic approves Roche drug Perjeta for patients with breast cancer

Basel, 15.08.2012 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Swissmedic (Swiss Agency for Therapeutic Products) has approved Perjeta in Switzerland.Perjeta is indicated in combination with Herceptin and docetaxel for the treatment of patients with HER2-positive metastatic or locally recurrent surgically unresectable breast cancer who have not previously received chemotherapy for their metastatic disease.1 About Perjeta (pertuzumab)Perjeta is a humanised monoclonal antibody being studied in the early and advanced stages of HER2-positive breast cancer and advanced HER2-positive stomach cancer. As an HER2 dimerisation inhibitor (HDI), pertuzumab is the first investigational medicine developed to specifically prevent the HER2 receptor from dimerising (pairing) with other HER receptors (EGFR/HER1, HER3 and HER4).HER dimerisation is believe to play an important role in the growth and formation of several different cancer types. By preventing receptor binding, pertuzumab blocks cell signalling, which may ultimately lead to inhibition of cancer cell growth or to the death of the cancer cell. Binding of Perjeta to HER2 may also target cancer cells for destruction by the body’s immune system.The mechanisms of action of pertuzumab and Herceptin are believed to complement each other as both bind to the HER2 receptor but on different regions. The combination of Perjeta with Herceptin and chemotherapy is thought to achieve a more comprehensive blockade of HER signalling pathways.

Roche has also submitted a marketing licence application to the European Medicines Agency (EMA) for Perjeta in the treatment of patients with previously untreated HER2-positive mBC. This application is still being considered by the EMA.