medwireNews: The US FDA has given the go-ahead for the addition of pertuzumab to adjuvant trastuzumab and chemotherapy for patients with early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer at high risk for recurrence after resection.
The approval is based on the results of the phase III APHINITY trial, which showed a reduced incidence of invasive disease-free survival (IDFS) events with pertuzumab versus placebo in patients with high-risk disease. Specifically, invasive disease occurred in 8.2% of pertuzumab-treated participants with hormone receptor-negative breast cancer and in 10.6% of their placebo-treated counterparts. And among those with node-positive disease, the corresponding rates of IDFS events were 9.2% and 12.1%.
Pertuzumab – a first-in-class HER dimerization inhibitor – should be initiated at a loading dose of 840 mg over a 60-minute intravenous infusion, after which it should be given in 3-weekly cycles at a dose of 420 mg over 30–60 minutes.
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