Roche has announced the US Food and Drug Administration (FDA) has approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC) at high risk of recurrence. People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles). The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimetres in diameter or node-positive). People receiving the neoadjuvant Perjeta-based regimen should continue Perjeta and Herceptin after surgery to complete one year of treatment.

“The goal of treating breast cancer early is to provide people with the best chance for a cure. While we come closer to this goal with each advance, many people still have a recurrence and progress to the metastatic stage,” said Sandra Horning, MD, Roche's chief medical officer and head of Global Product Development. “Today’s approval of Perjeta means people with HER2-positive early breast cancer at high risk of recurrence have a new, clinically meaningful treatment option to reduce the chances of their disease returning.”

The FDA-approved use of the Perjeta-based regimen for adjuvant treatment of HER2-positive eBC at high risk of recurrence is based on results of the phase III APHINITY study. At the time of the primary analysis with a median of 45.4 months follow-up: In the overall study population, Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 18% compared to Herceptin and chemotherapy alone (HR=0.82, 95% CI 0.67-1.00, p=0.047).High-risk patients included patients such as those with lymph node-positive or hormone receptor-negative breast cancer. The subgroup results were as follows: Lymph node-positive subgroup (HR=0.77, 95% CI 0.62-0.96), Hormone receptor-negative subgroup (HR=0.76, 95% CI 0.56-1.04), Hormone receptor-positive subgroup (HR=0.86, 95% CI 0.66-1.13), Lymph node-negative subgroup (HR=1.13, 95% CI 0.68-1.86)

The most common severe (Grade 3-4) side effects with the Perjeta-based regimen are low levels of white blood cells with or without a fever, diarrhoea, decrease in certain types of white blood cells, decrease in red blood cells, fatigue, nausea and mouth blisters or sores. The most common side effects are diarrhoea, nausea, hair loss, fatigue, nerve damage and vomiting.

The supplemental Biologics License Application for the Perjeta-based regimen for adjuvant treatment of HER2-positive eBC was granted Priority Review,2 a designation given to medicines the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

The combination of Perjeta, Herceptin and chemotherapy is licensed as a neoadjuvant treatment for people with HER2-positive eBC in more than 85 countries worldwide. Perjeta in combination with Herceptin and docetaxel chemotherapy is also approved in the US and the European Union for people with previously untreated HER2-positive metastatic breast cancer.