The U.S. Food and Drug Administration approved Roche Holding AG's Perjeta, in combination with Herceptin and chemotherapy, for adjuvant treatment of a type of breast cancer.
Roche's Perjeta combination treatment was approved for post-surgical treatment of HER2-positive early breast cancer at high risk of recurrence.
The agency's approval is based on a phase 3 study, which showed that the drug combination significantly reduced the risk of invasive breast cancer recurrence or death compared to Herceptin and chemotherapy alone.
The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant, or before surgery, treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer.
Perjeta is also approved for use in combination with Herceptin and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
