The European Union (EU) Committee for Medicinal Products for Human Use (CHMP) has recommended for approval Roche's Perjeta along with Herceptin and chemotherapy for neoadjuvant treatment of adult patients with HER2-positive early breast cancer.
The recommendation to the European Commission was based primarily on data obtained from the Phase II NeoSphere study.
The study showed nearly 40% of people receiving the Perjeta regimen lacked detectable tumour tissue at the time of surgery in the affected breast and local lymph nodes, also called pathological complete response (pCR).
In comparison, only 21.5% of people treated with Herceptin and taxane chemotherapy alone could achieve pCR.
"Breast cancer treatment has the greatest impact in the early stage, where it can potentially prevent the disease from returning and spreading."The submission was also supported by efficacy and safety data gathered from another neoadjuvant study, dubbed Tryphaena, as well as long-term safety results from the Cleopatra trial in people with previously untreated HER2-positive advanced breast cancer (aBC).
Roche chief medical officer and global product cevelopment head Dr Sandra Horning said: "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.
"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."
Meanwhile, the broader role of Perjeta in the treatment of HER2-positive early breast cancer (eBC) is likely to be informed by the data from the ongoing Phase III Aphinity study in the adjuvant setting.
Already approved as a neoadjuvant treatment for people with HER2-positive eBC in the US and 20 other countries, Perjeta targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers.
Specifically, the medicine prevents the HER2 receptor from pairing with other HER receptors such as EGFR/HER1, HER3 and HER4 on the surface of cells, which is believed to play a role in growth and survival of a tumour.
Approximately 100,000 people are claimed to be diagnosed with HER2-positive breast cancer in Europe every year.
