FDA Approves Roche’s Perjeta

Roche announced the US Food and Drug Administration 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). 

“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. The most common side effects are diarrhoea, nausea, hair loss, fatigue, nerve damage and vomiting.