The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of neratinib (Nerlynx) for the extended adjuvant treatment of adult patients with early stage hormone receptor–positive, HER2-overexpressed/amplified breast cancer following postoperative trastuzumab (Herceptin).
The European Commission will now review the CHMP recommendation and make a final decision on whether to approve neratinib for use in the European Union.
In the United States, the FDA approved neratinib in July 2017 for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following adjuvant trastuzumab. The agency reviewed data from the phase III ExteNET trial and the phase II CONTROL trial. In the available data at the time of the review, the primary analysis of the ExteNET trial showed that the invasive disease-free survival (iDFS) rate at 2 years was 94.2% with neratinib versus 91.9% with placebo (stratified hazard ratio [HR], 0.66; 95% CI, 0.49-0.90; stratified log-rank P
-value [two-sided] =.008).
... to read the full story