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ExteNET was a pivotal phase 3, global, multicenter, randomized, double-blind, placebo-controlled study2,3

NERLYNX is the first and only HER2-directed small molecule approved in HER2+ early breast cancer3,21

  • Study population: 2840 women with early stage HER2+ breast cancer; locally confirmed HER2 status; all patients had prior trastuzumab-based therapy
  • Primary endpoint: invasive disease-free survival (iDFS)*
  • Secondary endpoints: overall survival, DFS–DCIS, distant DFS, time to distant recurrence, CNS metastases, safety
  • Stratification: nodes 0, 1-3 vs 4+, ER/PR status, concurrent vs sequential trastuzumab-based therapy

CNS: central nervous system; DFS-DCIS: disease-free survival including ductal carcinoma in situ; DFS: disease-free survival; ER: estrogen receptor; HER: human epidermal growth factor receptor; PR: progesterone receptor.

*Invasive disease-free survival defined as the time between the date of randomization to the first occurrence of invasive recurrence (local/regional, ipsilateral, or contralateral breast cancer), distant recurrence, or death from any cause, with 2 years and 28 days of follow-up.3

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

Select exclusion criteria: clinically significant cardiac, GI, or psychiatric comorbidities; inability to swallow pills.2

Patient characteristics were balanced in the ExteNET trial2

22

ER: estrogen receptor; PR: progesterone receptor.

*Percentage is based on the number of hormone receptor-positive patients. Tumors were assessed as being ER or PR positive on the basis of local pathology laboratory cutoffs. There was no protocol specification as to whether a 1% or 10% threshold should be used.

The number of patients who received neoadjuvant chemotherapy was 342 (24%) in the NERLYNX group and 379 (27%) in the placebo group.

See ExteNET efficacy data

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.