Perjeta recommended for approval in EU for use before surgery in HER2-positive early breast cancer

Posted: 29 June 2015 |

The CHMP has recommended that the EC approves the use of Perjeta for the neoadjuvant treatment of adult patients with HER2-positive early breast cancer…

The EU Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approves the use of Roche’s Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.


The EU filing was based primarily on data from the Phase II NeoSphere study, which showed that nearly 40% of people receiving the Perjeta regimen had no evidence of tumour tissue detectable at the time of surgery in the affected breast and local lymph nodes (known as a pathological complete response, or pCR) compared to 21.5% of people who received Herceptin and taxane chemotherapy alone. 

Every year, approximately 100,000 people in Europe are diagnosed with HER2-positive breast cancer, an aggressive type of the disease that is likely to progress more quickly than cancer that is HER2-negative. The majority of breast cancer cases are diagnosed at an early stage of the disease, before the cancer has spread to other parts of the body.

Perjeta is already approved as a neoadjuvant treatment in the US

“Breast cancer treatment has the greatest impact in the early stage, where it can potentially prevent the disease from returning and spreading. Consequently, there is a need to bring promising treatments to patients with early breast cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are very pleased that the use of pCR as a novel clinical trial endpoint may hopefully soon allow us to make the Perjeta regimen available to patients with early breast cancer in Europe.”

Perjeta is already approved as a neoadjuvant treatment for people with HER2-positive eBC in the US and 20 other countries.

Follow-up data from the NeoSphere study were presented at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. These data suggest that, at three years, people who received the Perjeta regimen prior to surgery were 31% less likely to experience disease worsening, recurrence or death compared to those who received Herceptin and chemotherapy. People treated with the Perjeta regimen were also 40% less likely to experience disease recurrence or death.

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