Puma Biotechnology announced the launch of Nerlynx (neratinib) for the extended adjuvant treatment of adults with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.
The approval was supported by data from the Phase 3 multicenter, randomized, double-blind, placebo-controlled ExteNET trial (n=2,840) following adjuvant treatment with trastuzumab. Women with early stage HER2+ breast cancer were randomized to either Nerlynx or placebo for 1 year. The data showed invasive disease-free survival (iDFS) was seen in 94.2% of patients treated with Nerlynx vs. 91.9% in patients who received placebo after follow-up of 2 years (hazard ratio [HR] 0.66, 95% CI: 0.49, 0.90; P=0.008).
The most frequently reported adverse effects were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST/ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight loss, and urinary tract infection.
Nerlynx, a kinase inhibitor, initially received approval from the Food and Drug Administration (FDA) in July 2017. Nerlynx is available as 40mg strength tablets in 126- and 180-count bottles.
For more information call (844) 637-5969 or visit Nerlynx.com.