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.
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