Herceptin® (Trastuzumab) Approved as Monotherapy in Adjuvant Breast Cancer Setting

The United States Food and Drug Administration (FDA) has expanded the indication of Herceptin to be used as monotherapy for the adjuvant treatment of HER2-positive breast cancer.

The new indication was based on follow-up results from HERA, in which the group of patients who continued on Herceptin monotherapy following combination therapy had a 46% reduction in recurrences than those who were not on Herceptin.

Heart failure occurred in 2% of patients treated with Herceptin, and 0.3% of patients in the control group.