42% reduction in risk of recurrence*,†
95% of the patients with HER2+, HR+ disease had concomitant endocrine therapy.2
NERLYNX prevents recurrence1,*
DESCRIPTIVE ANALYSES: INVASIVE DISEASE-FREE SURVIVAL (iDFS) AT 5 YEARS IN HER2+, HR+ POPULATION PATIENTS COMPLETING PRIOR TRASTUZUMAB-BASED THERAPY ≤1 YEAR FROM RANDOMIZATION (n=1334)
42% reduction in risk of recurrence*,†
95% of the patients with HER2+, HR+ disease had concomitant endocrine therapy.2
*Recurrence was defined as time from randomization to first occurrence of invasive ipsilateral tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence, or death from any cause.
†Results of ExteNET are supported by an exploratory analysis of 5-year follow-up, with 74.5% (2117/2840) of patients reconsented.2
CI: confidence interval; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor-positive; ITT: intent-to-treat.
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Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Please see additional IMPORTANT SAFETY INFORMATION below.
Invasive disease-free survival (iDFS) benefit across several prespecified subgroups
ITT POPULATION: iDFS BENEFIT AT 2 YEARS, BY SUBGROUP21
CI: confidence interval; HR: hazard ratio; ITT: intent-to-treat.
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Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
Lactation: Advise women not to breastfeed.
Please see additional IMPORTANT SAFETY INFORMATION below.
NERLYNX prevents recurrence in patients who did not achieve a pCR1,*
DESCRIPTIVE ANALYSES: INVASIVE DISEASE-FREE SURVIVAL (iDFS) AT 5 YEARS IN HER2+ HR+ PATIENTS WHO COMPLETED PRIOR TRASTUZUMAB-BASED THERAPY ≤1 YEAR FROM RANDOMIZATION AND DID NOT ACHIEVE A pCR (n=295)†
40% reduction in risk of recurrence*,†
*Recurrence is defined as the time from randomization to first occurrence of invasive ipsilateral tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence, or death from any cause.
†Results of ExteNET are supported by descriptive analyses after 5 years of follow-up, with 74.5% of patients (2117/2840) reconsented. 95% of the patients with HER2+ HR+ disease had concomitant endocrine therapy. Data in HER2+ HR+ patients who did not achieve a pCR were derived from a descriptive subgroup analysis.2
CI: confidence interval; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor–positive; ITT: intent-to-treat; pCR: pathologic complete response.
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ADVERSE REACTIONS:
The most common adverse reactions (reported in ≥5% of patients) were:
Please see additional IMPORTANT SAFETY INFORMATION below.
NERLYNX increases overall survival (OS) in patients who did not achieve a pCR1
DESCRIPTIVE ANALYSES: OS AT 8 YEARS IN HER2+ HR+ PATIENTS WHO COMPLETED PRIOR TRASTUZUMAB-BASED THERAPY ≤1 YEAR FROM RANDOMIZATION AND DID NOT ACHIEVE A pCR (n=295)*
53% reduction in risk of death*
*95% of the patients with HER2+ HR+ disease had concomitant endocrine therapy. Data in HER2+ HR+ patients who did not achieve a pCR were derived from a descriptive subgroup analysis.1,2
CI: confidence interval; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor–positive; pCR: pathologic complete response.
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Drug interactions: 1. Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. 2. Strong CYP3A4 inhibitors: Avoid concomitant use. 3. Moderate CYP3A4 and P-glycoprotein (P-gp) dual inhibitors: Avoid concomitant use. 4. Strong or moderate CYP3A4 inducers: Avoid concomitant use. 5. P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
Please see additional IMPORTANT SAFETY INFORMATION below.
NERLYNX prevents CNS metastases in patients who did not achieve a pCR1
DESCRIPTIVE ANALYSES: HER2+ HR+ PATIENTS COMPLETING PRIOR TRASTUZUMAB-BASED THERAPY ≤1 YEAR FROM RANDOMIZATION WHO DID NOT ACHIEVE A pCR (n=295)*
0.8% (95% CI: 0.1%-4.0%) of patients (n=131) experienced CNS recurrence as the first site of metastases with NERLYNX vs 3.6% (95% CI: 1.3%-7.8%) of patients (n=164) with placebo.
76% reduction in the risk of CNS recurrence or death from any cause 98.4% (95% CI: 93.6%-99.6%) of patients (n=131) experienced CNS-DFS at 5 years with NERLYNX vs 92.0% (95% CI: 85.6%-95.7%) of patients (n=164) with placebo (HR=0.24; 95% CI: 0.04-0.92).
*Results of ExteNET are supported by descriptive analyses after 5 years of follow-up, with 74.5% of patients (2117/2840) reconsented. Data in HER2+ HR+ patients who did not achieve a pCR were derived from a descriptive subgroup analysis.1,2
CI: confidence interval; CNS: central nervous system; CNS-DFS: central nervous system disease-free survival; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor–positive; pCR: pathologic complete response.
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Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Please see additional IMPORTANT SAFETY INFORMATION below.
IMPORTANT SAFETY INFORMATION
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS: The most common adverse reactions (reported in ≥5% of patients) were:
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS:
USE IN SPECIFIC POPULATIONS:
For Full Prescribing Information, please click here.
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