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NERLYNX prevents recurrence1,*

INVASIVE DISEASE-FREE SURVIVAL (iDFS) IN HER2+, HR+ POPULATION: PATIENTS COMPLETING PRIOR TRASTUZUMAB-BASED THERAPY ≤1 YEAR FROM RANDOMIZATION1

iDFS chart

42% reduction in risk of recurrence*,†

95% of the patients with HER2+, HR+ disease had concomitant endocrine therapy.2

iDFS in the ITT population (N=2840): 94.2% with NERLYNX (95% CI: 92.6%, 95.4%) vs 91.9% with placebo (95% CI: 90.2%, 93.2%) at 2 years (HR=0.66; 95% CI: 0.49, 0.90; P=0.008)3
  • 72% of patients in the ExteNET ITT population had stage II or III disease (41% stage II, 31% stage III). Staging was unknown for 18% of patients3

CI: confidence interval; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor-positive; ITT: intent-to-treat.

*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.1

Results of ExteNET are supported by an exploratory analysis of 5-year follow-up, with 74.5% (2117/2840) of patients reconsented.2

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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.

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NERLYNX prevents distant recurrence1,*

DISTANT DISEASE–FREE SURVIVAL (DDFS) IN HER2+, HR+ population: patients completing prior trastuzumab-BASED THERAPY ≤1 year from randomization1

DDFS chart

43% reduction in risk of distant recurrence*,†

95% of the patients with HER2+, HR+ disease had concomitant endocrine therapy.2

CI: confidence interval; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor-positive;

*Distant recurrence is defined as the first occurrence of distant recurrence or death from any cause.2

Results of ExteNET are supported by an exploratory analysis of 5-year follow-up, with 74.5% (2117/2840) of patients reconsented.2

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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.

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NERLYNX prevents recurrence in patients who did not achieve a PCR1,*

INVASIVE DISEASE–FREE SURVIVAL (iDFS) IN HER2+, HR+ POPULATION WHO DID NOT ACHIEVE A PCR AFTER NEOADJUVANT THERAPY: PATIENTS COMPLETING PRIOR TRASTUZUMAB-BASED THERAPY ≤1 YEAR FROM RANDOMIZATION

iDFS chart

40% reduction in risk of recurrence*

95% of the patients with HER2+, HR+ disease had concomitant endocrine therapy.2

CI: confidence interval; HER: human epidermal growth factor receptor; HR: hazard ratio; HR+: hormone receptor-positive; pCR: pathologic complete response.

*Recurrence is defined as an invasive-disease event or death.1

Results of ExteNET are supported by an exploratory analysis of 5-year follow-up, with 74.5% (2117/2840) of patients reconsented.2

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The most common adverse reactions (reported in ≥5% of patients) were:

  • NERLYNX as a single agent: diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
  • NERLYNX in combination with capecitabine: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

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NERLYNX prevents recurrence across prespecified subgroups

ITT POPULATION: INVASIVE DISEASE-FREE SURVIVAL (iDFS) BENEFIT AT 2 YEARS, BY SUBGROUP

3 3 22 3 22 3

CI: confidence interval; HR: hazard ratio; ITT: intent-to-treat.

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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.

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Learn about adverse events

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.