About recurrence

Trastuzumab has improved but not eliminated the risk of recurrence in early-stage HER2+ breast cancer

HERA trial long-term disease-free survival* (DFS) outcomes

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face a disease-free survival event or death* within 11 years as observed in the HERA trial.
A substantial unmet need still exists.7

HER2: human epidermal growth factor receptor 2

Disease-free survival, defined as time from randomization to the first occurrence of any of the following disease-free survival events: recurrence of breast cancer at any site; the development of ipsilateral or contralateral breast cancer, including ductal carcinoma in situ but not lobular carcinoma in situ; second nonbreast malignant disease other than basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix; or death from any cause without documentation of a cancer-related event.4

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com 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.