FDA Approves Nerlynx for HER2-Positive Breast Cancer Treatment

Nerlynx (neratinib) was granted approval by the Food and Drug Administration (FDA) for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer who have already received postoperative Herceptin (trastuzumab).
BY JASON M. BRODERICK @jasoncology
PUBLISHED: JULY 17, 2017

Nerlynx (neratinib) was granted approval by the Food and Drug Administration (FDA) for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer who have already received postoperative Herceptin (trastuzumab).


The approval, which follows a 12-4 recommendation from the FDA’s Oncologic Drugs Advisory Committee, was based on data from the phase 3 ExteNET trial and the phase 2 CONTROL trial. In the primary analysis of the ExteNET trial, the invasive disease-free survival (iDFS) rate at two years was 94.2 percent with neratinib versus 91.9 percent with placebo.


The results indicated that the benefit may vary based on hormone receptor (HR) status. An exploratory subgroup analysis indicated that Nerlynx lowered the risk of recurrence by 51 percent in HR-positive patients, compared with 7 percent in HR-negative patients.


Diarrhea was the primary safety concern that associated with Nerlynx, as 95 percent of patients in the ExteNET trial who received the tyrosine kinase inhibitor experienced the adverse event (AE), including grade 3 diarrhea in 40 percent of patients. Diarrhea led to study discontinuation for 16.8 percent of patients. However, results from the ongoing phase 2 CONTROL trial suggest that antidiarrheal prophylaxis can control the occurrence and severity of diarrhea among patients receiving Nerlynx.

In the ExteNET study, 2840 patients who remained disease-free following one year of treatment with adjuvant Herceptin and chemotherapy were randomized to Nerlynx (1,420 patients) or placebo (1,420 patients). Nerlynx was administered for 12 months at 240 mg per day. In the final study amendment, the primary endpoint was iDFS at two years and 28 days from randomization. The median age of patients in the study was 52 years and approximately 24 percent had node negative disease, with 47 percent of patients having one to three positive nodes and 30 percent having at least four positive nodes. Anthracyclines were administered as adjuvant chemotherapy in the majority (77 percent) of patients. Appropriate endocrine therapy was administered to 94 percent of patients with HR-positive breast cancer.



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