The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-4 recommending approval of neratinib (Nerlynx) for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin).
The safety analysis for the primary ExteNET data review was based on 1408 patients from the neratinib arm and 1408 patients from the placebo arm. The median duration of exposure to neratinib and placebo was 11.6 months and 11.8 months, respectively.
In the neratinib arm, grade 3/4 AEs occurred in 50% of patients and led to treatment discontinuation in 28% of patients. The most common AEs leading to neratinib discontinuation were diarrhea (16.8%), vomiting (3.8%), and nausea (2.8%). In the neratinib arm, 7.3% of patients experienced non-fatal serious AEs, the most frequent being diarrhea in 22 patients versus 1 patient in the placebo arm.
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