Pertuzumab has been approved for the treatment of human epidermal growth factor receptor (HER) 2–positive breast cancer patients at high risk of recurrence, according to the Food and Drug Administration.
The approval was based on results from the APHINITY trial , which included 4,804 patients who had HER2-positive early breast cancers that were excised prior to the study. After a median follow-up period of 45.4 months, an invasive disease event occurred in 7.1% of all patients who received pertuzumab (Perjeta) and in 8.7% of patients who received placebo. In patients with hormone receptor–negative disease, invasive events occurred in 8.2% of the pertuzumab group and in 10.6% of the placebo group. In patients with node-positive disease, the invasive event rate was 9.2% in the pertuzumab group and 12.1% in the placebo group.
The most common adverse events associated with pertuzumab were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting; the most common severe adverse events were neutropenia, febrile neutropenia, diarrhea, decreased neutrophil count, anemia, decreased white blood cell count, leukopenia, fatigue, nausea, and stomatitis.
“The initial pertuzumab dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30- to 60-minute intravenous infusion,” the FDA said in the statement.
Find the full statement on the FDA website .