BRIEF—Roche gains regular approval for Perjeta combo in breast cancer

The US Food and Drug Administration has approved Roche’s (ROG: SIX) Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy as adjuvant treatment for certain breast cancer patients.

The drug was developed by the Swiss firm’s biotech arm Genentech.

Approval was based on data from the APHINITY trial, in which the therapy produced improved disease-free survival (IDFS) compared with placebo.

The trial met post-marketing requirements mandated under the FDA’s prior accelerated approval for this indication, which is now converted to regular approval.