Genentech’s Perjeta (pertuzumab) secured the FDA’s approval for use in combination with Herceptin (trastuzumab) and chemotherapy.
Under the regular approval, the drug can be used as an adjuvant treatment of patients with early breast cancer at high risk of recurrence.
The FDA based the approval on data from a 4,804-patient trial. The trial found improved invasive disease-free survival in subjects, although overall survival data are not yet mature.
The agency granted regular approval for the drug in metastatic breast cancer patients who have not yet received chemotherapy in 2012.