FDA grants breast cancer approval to Roche's Perjeta/Herceptin combo therapy

Roche has announced that the FDA has granted approval to Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and a (Perjeta-based) chemotherapy regimen for the adjuvant treatment of HER2-positive early breast cancer which is at a high chance of recurrence.

The FDA based its decision on Phase 3 data which showed that the regimen in question was more effective than Herceptin and chemotherapy alone, cutting the risk of invasive breast cancer recurrence or death by 18%.

As part of the appraisal, the US regulator also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer.

The regimen is to be administered to patients for a full year, and those receiving the neoadjuvant Perjeta-based regimen are advised to continue Perjeta and Herceptin after surgery to complete a full year’s 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," commented Roche's Chief Medical Officer and Head of Global Product Development, Sandra Horning. "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."