EC approves Perjeta regimen for breast cancer

The European Commission has approved the use of Perjeta (pertuzumab) from Swiss drug major Roche (SIX: ROG) in combination with Herceptin (trastuzumab) and chemotherapy.

The combination is approved for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the EC based on pCR data. pCR is achieved when there is no tumor tissue detectable at the time of surgery in the affected breast or in the affected breast and local lymph nodes. It is a common measure of neoadjuvant treatment effect in breast cancer and it can be assessed more quickly than traditional endpoints in eBC.

Sandra Horning, Roche’s chief medical officer and head, global product development, said: “Today’s approval is a significant milestone in the neoadjuvant treatment of HER2-positive early breast cancer, bringing Perjeta to patients years earlier than typical adjuvant treatment. We are committed to making the Perjeta regimen available to appropriate patients in the EU as early as possible.”