EU Recommends Approval of Roche’s Pre-Surgery Breast Cancer Treatment

In In The News, Uncategorized by Barbara Jacoby


Roche announced that the EU Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approves the use of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy for the neoadjuvant treatment (use before surgery) 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 2 NeoSphere study, which showed that nearly 40 percent 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 percent of people who received Herceptin and taxane chemotherapy alone. This is the first CHMP recommendation in the neoadjuvant setting based on pCR.

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.

“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.”

The CHMP opinion was provided in the context of the totality of Perjeta data available to date, including the biological rationale for the combination of Perjeta, Herceptin and taxane chemotherapy, its established safety profile and the efficacy results in the advanced breast cancer (aBC) setting. The submission was supported by efficacy and safety data from two neoadjuvant studies, NeoSphere and TRYPHAENA, as well as long-term safety results from the CLEOPATRA trial in people with previously untreated HER2-positive aBC. Data from the ongoing Phase III APHINITY study in the adjuvant (post-surgery) setting will provide additional insights into the broader role of Perjeta in the treatment of HER2-positive early breast cancer (eBC).

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