Health Canada has given approval to the Neratinib for the treatment of patients with early-stage, hormone receptor (HR)–positive, HER2-overexpressed/amplified breast cancer in the extended adjuvant setting. The agent should be given to patients a year after completing trastuzumab-based adjuvant therapy.
Findings from the phase 3 ExteNET trial supported the approval, showing a 2-year invasive disease-free survival rate of 95.3 percent in those who received neratinib compared with 90.8 percent in the control arm for this patient population. Knight Therapeutics Inc., which is a licensing partner of neratinib’s manufacturer Puma Biotech, made an announcement regarding the approval in a press release.
The chief executive officer of Knight, Jonathan Ross Goodman stated that Health Canada has given approval which marks the first time Canadian women are being presented with an opportunity for extended-adjuvant therapy which will lead to a reduction in the risk of disease recurrence in patients who would otherwise have had a relapse.
In the multi-center, double-blind, randomized, controlled ExteNET trial, investigators assessed neratinib following adjuvant trastuzumab treatment in 2840 patients with early-stage HER2-positive breast cancer were randomized to receive either neratinib or placebo for a year.
The average age was 52 years & around 23.8 percent of patients had the node-negative disease; 46.6 percent of patients had 1 to 3 positive nodes and 29.6 percent had greater than 4 positive nodes. Anthracyclines were administered as adjuvant chemotherapy in 77 percent of patients, and suitable endocrine therapy was administered to 94 percent of patients.
Results at two years of follow-up indicated that treatment with neratinib led to a 51 percent reduction in the risk invasive disease recurrence or death of two years compared with placebo. Updated findings indicated that at an average follow-up of 5.2 years, the iDFS rate with neratinib was 90.2 percent compared with 87.7 percent with control, resulting in a 27 percent reduction in the risk of invasive disease recurrence or death.