Nerlynx (neratinib) Approved For HER2-Positive MBC

The United States Food and Drug Administration (US FDA) approved Nerlynx (neratinib) for the treatment of metastatic breast cancer. Nerlynx is used in combination with the chemotherapy drug capecitabine. Specifically, Nerlynx was approved for use in adults with HER2-positive breast cancer who have tried at least 2 other anti-HER2 treatment options.

Nerlynx was approved two months ahead of its goal date and was given Fast Track designation. Programs like this help get drugs that treat serious or life-threating conditions to the market faster. Nerlynx can also be used in some cases of early-stage HER2-positive breast cancer.

How does Nerlynx work?

Nerlynx is part of a class of drugs called kinase inhibitors. It targets several receptors on breast cancer cells, including HER2 (human epidermal growth factor receptor 2). This receptor can send signals to cells and tell them to grow, allowing the cancer to spread. When drugs like Nerlynx interfere with these receptors and block the messages they are sending, the growth of cancer cells may be slowed or stopped. Since Nerlynx targets the HER2 receptor, it can only be used by people who have breast cancer that is HER2-positive.

Nerlynx in clinical trials

The approval of Nerlynx came after the FDA reviewed results from a large clinical trial. This trial was called the NALA trial, and included over 620 people with metastatic HER2-positive breast cancer. All participants had tried at least 2 other anti-HER2 treatment options. The people in the study were split into two groups. One group received Nerlynx while the other group received lapatinib (another anti-HER2 drug). Both groups also received capecitabine. Treatments were given in 21-day cycles until breast cancer progressed or side effects were too great.

The researchers studied the progression-free survival (PFS) of both groups. The PFS is the time until a person’s breast cancer started spreading while on treatment. They also assessed overall survival (OS) and objective response rate (ORR, the percentage of people whose cancer responded to the treatment). Some of the results are below:

  • The PFS rate at 12 months was 29 percent for those taking Nerlynx versus 15 percent of those not taking Nerlynx
  • The OS was 21 months for those taking Nerlynx versus 18.7 months for those not taking Nerlynx
  • The ORR was 33 percent for those taking Nerlynx versus 27 percent for those not taking Nerlynx

Those taking Nerlynx responded to the drug for 8.5 months versus 5.6 months for those not taking the drug. These results all indicate that Nerlynx may have advantages over currently available treatment options for people with metastatic breast cancer who have progressed on other anti-HER2 treatment options. This may especially be the case when it comes to overall survival, response rates, and time until cancer progression.

What are the side effects of Nerlynx?

The most common side effects of Nerlynx include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Fatigue
  • Decreased appetite
  • Weight loss
  • Back and joint pains
  • Muscle spasms
  • Dizziness
  • Urinary tract infection
  • Upper respiratory tract infection
  • Issues with kidney function

Things to know about Nerlynx

Nerlynx may cause severe diarrhea. Some people taking Nerlynx may need to take additional medications to manage their diarrhea, as well as receive fluids and electrolytes. Some may need to discontinue Nerlynx if diarrhea is too severe.

Nerlynx may cause liver issues. People taking Nerlynx may need to have their liver function monitored while taking the drug. If liver issues occur, Nerlynx will need to be stopped. Nerlynx can interact with other medications. Before starting Nerlynx, tell your doctor about any other medications you take, including vitamins and supplements.

Nerlynx can harm an unborn baby. Effective birth control options are needed if you are taking Nerlynx and you or your partner could become pregnant. It is not known whether Nerlynx can pass through breast milk. Women taking Nerlynx should not breastfeed.

Read the prescribing information to learn more about Nerlynx.

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