EU approves use of Perjeta (pertuzumab) plus Herceptin prior to surgery in early stage breast cancer- Roche

The EU has approved the use of Perjeta (pertuzumab), from Roche, 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 Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the EC based on pathological complete response data. Perjeta was previously approved in combination with Herceptin and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

The new approval is based primarily on data from the neoadjuvant Phase II NeoSphere study, which showed that nearly 40% of people receiving the combination of Perjeta, Herceptin and chemotherapy achieved pathological complete response (pCR) in the affected breast and local lymph nodes compared to 21.5% of people who received Herceptin and taxane chemotherapy alone. The approval was also supported by data from the Phase II neoadjuvant TRYPHAENA study, in which pCR rates ranging from 54.7% to 63.6% were achieved across the three Perjeta-containing study arms. Long-term safety results from the Phase III CLEOPATRA trial in people with previously untreated HER2-positive advanced breast cancer also supported the approval. 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 eBC.

Comment: This is the first approval in Europe based on pCR, a clinical endpoint that has allowed Perjeta to be made available to people with this aggressive disease faster than under typical review processes. Treating breast cancer early, before it has spread, may improve the chance of preventing the disease from returning and reaching an incurable stage.