HER2 (Human Epidermal Growth Factor Receptor 2) is a type of protein found on the surface of everyone’s cells. This protein tells cells how and when to grow and divide. However, HER2+ breast cancer cells have more HER2 receptors than normal breast cells. Having more HER2 receptors causes tumor cells to grow and divide faster, which increases the risk of the cancer coming back or spreading outside the breast.

Learn more about early-stage HER2+ breast cancer Learn more about metastatic HER2+ breast cancer

HER2+ breast cancer tends to be more aggressive and although some treatments have improved outcomes for patients, they have not eliminated the risk of cancer returning in patients with early-stage HER2+ disease. Up to 1 in 4 early-stage HER2+ breast cancer patients experience recurrence within 10 years after being treated with trastuzumab-based therapy (ie, Herceptin^®). The majority of disease recurrences involve cancer that has spread to other parts of the body (metastatic breast cancer).

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Metastatic breast cancer (mBC)—also called Stage 4 or advanced breast cancer—is cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body. Treatment can control metastatic breast cancer for some time, but often the cancer continues to grow or spread. A person’s experience with metastatic breast cancer will depend on how many metastases develop and where they are in the body.

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For early-stage breast cancer: NERLYNX is the first HER2-targeted medication approved by the US Food and Drug Administration (FDA) as extended adjuvant treatment for early-stage HER2+ breast cancer, which means that it’s designed to be taken by patients who have previously been treated with trastuzumab-based therapy (ie, Herceptin).

For metastatic breast cancer: NERLYNX is a HER2-targeted medication approved, in combination with capecitabine, by the US Food and Drug Administration (FDA) for metastatic breast cancer. It is designed to be taken by patients who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer.

For early-stage breast cancer: NERLYNX may be an option for you if you’re an adult with early-stage HER2+ breast cancer, and if you have previously been treated with trastuzumab-based therapy (ie, Herceptin).

For metastatic breast cancer: NERLYNX is used with a medicine called capecitabine to treat adults with HER2+ breast cancer that has spread to other parts of the body (metastatic) and who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer. It is not known if NERLYNX is safe and effective in children.

In people with breast cancer, cells receive signals that tell them to grow. NERLYNX is a type of treatment called a targeted therapy that works inside the cell to block these signals that tell the cells to grow and divide. By blocking HER2, breast cancer cells do not get the signal to grow and divide as rapidly.

For early-stage breast cancer: NERLYNX has been extensively studied in more than 4,000 patients, including in the ExteNET trial. ExteNET evaluated treatment with NERLYNX after adjuvant trastuzumab-based therapy in women with early-stage HER2+ breast cancer. In this clinical trial of 2,840 women, NERLYNX reduced the risk of cancer returning by 34% at 2 years for women studied with HER2+ breast cancer. The clinical trial also looked at a subset of women with HER2+ breast cancer who were also hormone receptor positive (HR+) and found there was a 42% reduction in the risk of recurrence at 5 years.*^,†

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For metastatic breast cancer: NERLYNX was studied in a clinical trial of 621 people who had HER2+ mBC and had undergone treatment with 2 or more HER2-directed treatments for mBC. The phase 3 study examined the effectiveness of NERLYNX plus capecitabine. The study compared people who took NERLYNX plus capecitabine (a chemotherapy) with people who took lapatinib (Tykerb^®) plus capecitabine. In the clinical trial, NERLYNX plus capecitabine reduced the risk of cancer progressing by 24% for all people studied who had undergone treatment with 2 or more HER2-directed treatments for mBC. People taking NERLYNX plus capecitabine responded to treatment longer than those taking lapatinib plus capecitabine (median of 8.5 months compared to 5.6 months for those taking lapatinib [Tykerb^®]).^‡,§

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*These are relative benefits. In absolute numbers, 94.2% of all people studied who were HER2+ and took NERLYNX had no return of cancer after 2 years, compared to the 91.9% of people on a placebo who had no return of cancer. After 5 years, 90.8% of all people studied who were HER2+ and HR+ and took NERLYNX had no return of cancer, compared to the 85.7% of people on a placebo who had no return of cancer.

^†5-year data are based on an exploratory analysis of people who were HR+ and had completed a trastuzumab-based treatment 1 year or less prior to treatment with NERLYNX. Of this HER2+, HR+ population, 95% were also on endocrine therapy.

^‡These are relative benefits. In absolute numbers, at 12 months, the progression-free survival rate was 29% in the NERLYNX plus capecitabine group (n=54) vs 15% in the lapatinib plus capecitabine group (n=24).

^§The 8.5 and 5.6 months durations were calculated only from the percentage of people that responded to therapy (32.8% in the NERLYNX group vs 26.7% in the lapatinib group).

For early-stage breast cancer: The most common side effects of NERLYNX when used alone include: diarrhea, nausea, stomach-area (abdomen) pain, tiredness, vomiting, rash, dry or inflamed mouth, or mouth sores, decreased appetite, muscle spasms, upset stomach, nail problems including color change, dry skin, swelling of your stomach-area, nosebleed, weight loss, and urinary tract infection. If you have any questions about the side effects you may experience while taking NERLYNX, please talk to your doctor or healthcare team.

For metastatic breast cancer: The most common side effects of NERLYNX in combination with capecitabine include: diarrhea, nausea, vomiting, decreased appetite, constipation, tiredness/weakness, weight loss, dizziness, back pain, joint pain, urinary tract infection, upper respiratory tract infection, swelling of your stomach-area, kidney problems, and muscle spasms.

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.

If you have already tested positive for HER2+ breast cancer, you should ask your healthcare team whether you need to be re-tested before taking NERLYNX. However, in order to receive NERLYNX for early-stage breast cancer, you must have had prior adjuvant treatment (after surgery) with trastuzumab-based therapy (ie, Herceptin). To receive NERLYNX for metastatic breast cancer, you must have taken 2 or more anti-HER2 therapy medicines for metastatic breast cancer.

NERLYNX is a treatment for HER2+ breast cancer patients only. Talk to your healthcare team about the treatment options that may be right for you.

NERLYNX is an oral medicine that works differently from other HER2 treatments and endocrine therapy. NERLYNX has been extensively studied in more than 4,000 patients, including in the ExteNET trial where 93% of HER2+, HR+ patients on NERLYNX were also taking endocrine therapy at the same time. If you have questions about your medication, such as how to take NERLYNX with your other medications, please speak with your healthcare team or pharmacist who can best answer them.

NERLYNX is covered by many insurance providers. For questions about insurance, the Puma Patient Lynx™ support program has resources for you to explore.

Your doctor can provide you with a prescription that is filled through a network of specialty pharmacies. If you have questions related to your specific situation, please speak with your healthcare team.

As with most medicines, side effects can occur with NERLYNX. Working with your healthcare team from the beginning is the key to success. Be sure to let your doctor know about any side effects that you experience and ask for help to manage them.

Your doctor can prescribe medication, recommend over-the-counter medicines, or alter your dose of NERLYNX to help. Diarrhea is the most common side effect.

Managing side effects for eBC Managing side effects for mBC

For early-stage breast cancer: The recommended dose of NERLYNX is 240 mg (six tablets, 40 mg each) taken by mouth once daily with food, continuously for one year.

Taking NERLYNX for eBC

For metastatic breast cancer: NERLYNX is an oral medicine that you take once a day. You will take NERLYNX in combination with capecitabine (a chemotherapy). For 14 days, you will take 6 NERLYNX tablets once a day plus capecitabine twice a day. After 14 days, you will stop taking capecitabine for 7 days. You will continue taking NERLYNX during this time. After 7 days, you will add capecitabine back again for 14 days. The cycle keeps repeating.

You will also need to take loperamide, an antidiarrheal, as prescribed by your physician during the first 2 months of NERLYNX treatment and then as needed.

Taking NERLYNX for mBC

If you miss a dose of NERLYNX, skip that dose and take your next dose at your regular scheduled time. If you have questions related to your specific situation, please speak with your healthcare team.

Puma Patient Lynx programs and services provide ongoing education, encouragement, and financial assistance. To learn more click here, or call 1-855-816-5421, Monday through Friday, 9 AM – 8 PM EST, to connect with someone.