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THE BENEFITS OF NERLYNX

NERLYNX was studied in a phase 3 clinical trial of 2,840 women who had early-stage HER2+ breast cancer. The majority of these women (81%) were enrolled within 1 year of completing trastuzumab-based treatment. The trial examined the safety and effectiveness of NERLYNX by comparing women who took NERLYNX with women who were given a placebo.

These women were followed over time—some for as long as approximately 8 years. During that time, the investigators also looked at a subset of women with HER2+ breast cancer who were also HR+ (hormone receptor positive), had initiated NERLYNX within 1 year of completing trastuzumab-based treatment, and had residual disease (no pathologic complete response, or pCR) at the time of surgery.

Participants were randomly selected to receive NERLYNX and were not told whether they were receiving the medicine or a placebo.

In the clinical trial, NERLYNX reduced the risk of cancer returning by 34% at 2 years for all women studied with HER2+ breast cancer.*

The clinical trial also looked at a subset of women with HER2+ breast cancer who were also HR+ and found there was a 42% reduction in the risk of recurrence at 5 years.†,‡

In a further subset of women who were HER2+ and HR+ and had residual disease after surgery (no pCR), the clinical trial found there was a 40% reduction in the risk of recurrence at 5 years.†,§

*In absolute numbers, 94.2% of all people studied who were HER2+ and HR+ and took NERLYNX had no return of cancer after 2 years, compared to the 91.9% of people on placebo—a difference of 2.3%.

5-year data are based on a descriptive analysis that included 75% of patients enrolled (2,117 out of 2,840) who agreed to remain in the study beyond the initial 2 years. This analysis looked at multiple subsets of patients who had completed a trastuzumab-based treatment 1 year or less prior to treatment with NERLYNX. Of the HER2+ and HR+ population, 95% were also on endocrine therapy.

After 5 years, 90.8% of people studied who were HER2+ and HR+ and took NERLYNX had no return of cancer, compared to the 85.7% of people on placebo—a difference of 5.1%.

§In absolute numbers, 85.0% of all people studied who were HER2+ and HR+, had residual disease (no pCR), and took NERLYNX had no return of cancer, compared to 77.6% of people on placebo—a difference of 7.4%.

NERLYNX EXTENDS SURVIVAL FOR SOME PATIENTS

At 8 years, an analysis of a subset of patients showed that NERLYNX extended the length of survival in women with HER2+ and HR+ breast cancer and residual disease (no pCR).

At 5 years, overall survival was 94.1% for those taking NERLYNX compared to 93.3% for those given placebo. After 8 years of follow-up, there was no statistically significant difference in survival between NERLYNX and placebo.

In a subset of women who were HER2+ and HR+, the clinical trial found that there was a 21% reduction in the risk of death at 8 years.†,‖

In a further subset of women who were HER2+ and HR+ and had residual disease after surgery (no pCR), there was a 53% reduction in the risk of death at 8 years.†,#

The absolute benefit of taking NERLYNX in overall survival at 8 years was 2.1% vs placebo in HER2+ and HR+ patients who had completed trastuzumab-based treatment 1 year or less prior to treatment with NERLYNX.

#The absolute benefit of taking NERLYNX in overall survival at 8 years was 9.1% vs placebo in HER2+ and HR+ patients who had residual disease and had completed trastuzumab-based treatment 1 year or less prior to treatment with NERLYNX.

PROTECTION AGAINST CNS (CENTRAL NERVOUS SYSTEM) METASTASES FOR SOME PATIENTS

In a descriptive analysis of a clinical trial, NERLYNX was shown to protect against CNS (brain and spinal cord) metastases in women with early-stage breast cancer who had residual disease (no pCR). At 5 years:

In HER2+ and HR+ women given NERLYNX, 0.7% had their first recurrence (metastases) in the CNS, compared to 2.1% given placebo.†,**

In a further subset of HER2+ and HR+ women who had residual disease (no pCR), 0.8% given NERLYNX had their first recurrence (metastases) in the CNS, compared to 3.6% given placebo.†,**

**In HER2+ and HR+ women, the absolute difference was 1.4%. In HER2+ and HR+ women who had residual disease (no pCR) and who had completed trastuzumab-based treatment 1 year or less prior to treatment with NERLYNX, the absolute difference was 2.8%.

††In absolute numbers, 98.4% of those given NERLYNX (n=670) did not experience a CNS recurrence or death from any cause, compared to 95.7% of those given placebo (n=664)—a benefit of 2.7%.

‡‡In absolute numbers, 98.4% of those given NERLYNX (n=131) did not experience a CNS recurrence or death from any cause, compared to 92.0% of those given placebo (n=164)—a benefit of 6.4%.

By committing to NERLYNX, you can be confident in knowing you are doing everything you can to lower your risk of your cancer coming back.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about NERLYNX (ner links)?

NERLYNX® (neratinib) may cause serious side effects, including:

Your healthcare provider may change your dose of NERLYNX, temporarily stop or completely stop NERLYNX if needed to manage your diarrhea.

See "What are the possible side effects of NERLYNX?" for more information about side effects.

What is NERLYNX?

It is not known if NERLYNX is safe and effective in children.

Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines used to decrease stomach acid, called proton pump inhibitors or PPIs. You should avoid taking these medicines during treatment with NERLYNX.

What are the possible side effects of NERLYNX?

NERLYNX may cause serious side effects, including:
See "What is the most important information I should know about NERLYNX?"


The most common side effects of NERLYNX when used alone include:

The most common side effects of NERLYNX in combination with capecitabine include:

These are not all of the possible side effects of NERLYNX. For more information, ask your Healthcare Provider.

Tell your doctor if you have any side effects that bother you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For Patient Information, please click here.