FDA Approves New Drug for HER-2 Positive Metastatic Breast Cancer

Pertuzumab (marketed as Perjeta) has been approved to treat HER2-positive metastatic breast cancer, the FDA announced late last week. The drug, indicated for treatment-naive patients, is used in combination with another anti-HER2 agent, trastuzumab, and the chemotherapy drug docetaxel.

Approval for the injectable drug — which targets a different part of the HER protein than trastuzumab — was based on a randomized trial of some 800 patients. Those who received the new drug as part of treatment survived about 6 months longer than those who didn't.

Pertuzumab will have a boxed warning about the potential risk for severe birth defects or death to fetuses. Common treatment side effects include diarrhea, hair loss, nausea, neutropenia, nerve damage, and rash.