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FDA Approves Nerlynx for HER2-Positive Metastatic Breast Cancer

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On Feb. 25, 2020, the U.S. Food and Drug Administration (FDA) approved the use of Nerlynx (chemical name: neratinib) in combination with the chemotherapy medicine Xeloda (chemical name: capecitabine) to treat people diagnosed with advanced or metastatic HER2-positive breast cancer who have already been treated with at least two anti-HER2 therapies for advanced breast cancer.

Advanced breast cancer is either locally advanced breast cancer or metastatic breast cancer. Locally advanced breast cancer is breast cancer that has spread to tissue near the breast, but not to parts of the body away from the breast. Metastatic breast cancer is cancer that has spread to parts of the body away from the breast, such as the bones or liver.

Read the FDA announcement.

About Nerlynx

Nerlynx was previously approved in July 2017 to treat early-stage, HER2-positive breast cancer for an extended period after surgery in people who have previously been treated with Herceptin (chemical name: trastuzumab). This new approval makes Nerlynx an option for some people with advanced-stage HER2-positive breast cancer as well.

Doctors call Nerlynx a HER2 inhibitor or anti-HER2 therapy, a type of targeted therapy that fights HER2-positive breast cancer by blocking the cancer cells’ ability to receive growth signals. Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Perjeta, Trazimera, and Tykerb are other HER2 inhibitors.

When taking Nerlynx to treat advanced or metastatic HER2-positive breast cancer, you take it with the chemotherapy Xeloda. Both Nerlynx and Xeloda are pills taken by mouth. The medicines are given together in a 21-day cycle:

  • you take Nerlynx once a day, every day, with food at the recommended dose of 240 mg (six pills)
  • you take Xeloda twice a day for 14 days, then stop for 7 days until the cycle starts over

You keep taking Nerlynx with Xeloda as long as you are getting benefits from the medicines and aren’t having troubling side effects.

Nerlynx research

The FDA’s approval of Nerlynx combined with Xeloda for advanced or metastatic HER2-positive breast cancer is based on results from the NALA study, which were presented on June 4, 2019, at the American Society for Clinical Oncology (ASCO) annual meeting.

Read the 2019 ASCO abstract: “Neratinib + capecitabine versus lapatinib + capecitabine in patients with HER2+ metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: Findings from the multinational, randomized, phase III NALA trial.”

The phase III NALA trial included 621 people with metastatic HER2-positive breast cancer. All of the people had been previously treated with at least two other anti-HER2 therapies for metastatic disease.

About half of the people were treated with Nerlynx and Xeloda, and the other half were treated with another anti-HER2 therapy called Tykerb (chemical name: lapatinib) and Xeloda. The people received these medicines until the cancer progressed or they had to stop treatment because of troubling side effects.

The people who were treated with Nerlynx and Xeloda had better progression-free survival than the people who were treated with Tykerb and Xeloda. Progression-free survival is how long a person lives without the cancer growing.

At 1 year:

  • 29% of the people who were treated with Nerlynx and Xeloda had no cancer progression
  • 15% of the people who were treated with Tykerb and Xeloda had no cancer progression

At 2 years:

  • 12% of the people who were treated with Nerlynx and Xeloda had no cancer progression
  • 3% of the people who were treated with Tykerb and Xeloda had no cancer progression

The improvement in progression-free survival in the people who were treated with Nerlynx and Xeloda was statistically significant, which means that it was likely due to the difference in treatment and not just because of chance.

The people who were treated with Nerlynx and Xeloda also had slightly better overall survival. Overall survival is how long a person lives, whether or not the cancer grows. Median overall survival was:

  • 21 months for the people who were treated with Nerlynx and Xeloda
  • 18.7 months for the people who were treated with Tykerb and Xeloda

This means that half of the people who were treated with Nerlynx and Xeloda lived longer than 21 months, and half did not. The difference in overall survival between the two groups was not significantly significant, which means that it could have happened by chance rather than because of the differences in treatment.

The overall response rate was also slightly higher in the group that was treated with Nerlynx and Xeloda, meaning more people in this group showed signs that the cancer responded to treatment. But this was not a statistically significant difference, meaning it could have been due to chance. The overall response rates were:

  • 32.8% in the people who were treated with Nerlynx and Xeloda
  • 26.7% in the people who were treated with Tykerb and Xeloda

The median response duration (the length of time between the first sign of response to treatment and cancer progression) was also longer in the group that was treated with Nerlynx and Xeloda. This was a statistically significant difference, which again means that it was likely due to the difference in treatment and not just because of chance. The median response durations were:

  • 8.5 months in the people who were treated with Nerlynx and Xeloda
  • 5.6 months in the people who were treated with Tykerb and Xeloda

Fewer people who were treated with Nerlynx and Xeloda needed treatment for central nervous system metastases (the cancer spreading to the brain or spinal cord). At 54 months, treatment for brain metastases was needed in:

  • 22.8% of the people who were treated with Nerlynx and Xeloda
  • 29.2% of the people who were treated with Tykerb and Xeloda

Nerlynx and Xeloda side effects

In the NALA study, more people treated with Nerlynx and Xeloda had grade 3 (severe) diarrhea than those treated with Tykerb and Xeloda (24.4% vs. 12.5%). But fewer people in the Nerlynx and Xeloda group had to stop treatment due to side effects than those in the Tykerb and Xeloda group (10.9% vs. 14.5%).

The most common severe side effects of treatment with Nerlynx and Xeloda are:

  • diarrhea
  • nausea
  • vomiting
  • decreased appetite
  • fatigue

What this means for you

If you’ve been diagnosed with advanced or metastatic HER2-positive breast cancer that has grown while being treated with at least two HER2 inhibitors, and you and your doctor are considering next treatments, you may want to talk to your doctor about treatment with Nerlynx and Xeloda.

Written by: Adam Leitenberger, editorial director

Reviewed by: Brian Wojciechowski, M.D., medical adviser


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