FDA Approves Pertuzumab Combination Therapy for HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
Approval was based on data from the APHINITY study (ClinicalTrials.gov identifier NCT01358877), a multicenter, randomized, double-blind, placebo-controlled trial in 4804 patients with HER2-positive early breast cancer who had their primary tumor excised. Patients were then randomized to receive pertuzumab or placebo, in combination with adjuvant trastuzumab and chemotherapy.
After a median follow-up of 45.4 months, the proportion of invasive disease–free survival events in the intent-to-treat population was 7.1% in the pertuzumab arm and 8.7% for those receiving placebo. The proportion of invasive disease–free survival events for patients with node-positive disease was 9.2% and 12.1% in the pertuzumab and placebo arms, respectively. Overall survival data are not yet mature.
Adverse reactions reported in at least 30% of patients receiving pertuzumab in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting. The most common grade 3/4 adverse reactions (> 2%) were neutropenia, febrile neutropenia, diarrhea, neutrophil count decreased, anemia, white blood cell count decreased, leukopenia, fatigue, nausea, and stomatitis.