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FDA Approves Injectable Herceptin for HER2-Positive Breast Cancer

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On Feb. 28, 2019, the U.S. Food and Drug Administration (FDA) approved an injectable form of Herceptin (chemical name: trastuzumab) called Herceptin Hylecta (chemical name: trastuzumab and hyaluronidase-oysk) to treat people diagnosed with HER2-positive breast cancer.

The approval is based on results from the HannaH trial and the SafeHER studies showing that Herceptin Hylecta is as effective and as safe as Herceptin.

Read the FDA announcement.

About Herceptin Hylecta

Herceptin Hylecta is a combination of Herceptin and hyaluronidase, an enzyme that helps your body use the Herceptin.

Traditional Herceptin is given by intravenous (IV) infusion, which means the medicine is delivered directly into your bloodsteam through an IV or port. The first dose of Herceptin takes about 90 minutes. After that, it only takes about 30 minutes to get other doses of Herceptin.

Herceptin Hylecta is given subcutaneously, which means it is injected under your skin using a hypodermic needle, much like a vaccine. The injection takes about 2 to 5 minutes and is given in your thigh, alternating between left and right for each dose.

It’s important to know that Herceptin Hylecta is given in different doses than IV Herceptin. Herceptin Hylecta is given at a fixed dose of 600 milligrams, while the dose of IV Herceptin is based on your weight.

You can receive a Herceptin Hylecta injection at an infusion center along with a chemotherapy regimen. If you are being treated with only Herceptin Hylecta, you may be able to receive the injection at your doctor’s office.

Herceptin Hylecta is approved to treat HER2-positive breast cancer that has spread to the lymph nodes (node-positive), or is not in the lymph nodes but is considered to be at high risk of recurrence:

  • after surgery as part of a treatment regimen that includes Adriamycin (chemical name: doxorubicin), Cytoxan (chemical name: cyclophosphamide), and either Taxol (chemical name: paclitaxel) or Taxotere (chemical name: docetaxel)
  • after surgery as part of a treatment regimen with Taxotere and carboplatin
  • after surgery as a single treatment for people who have been treated with a chemotherapy regimen that includes an anthracycline

Herceptin Hylecta also is approved to treat metastatic HER2-positive breast cancer:

  • in combination with Taxol as the first treatment for metastatic disease
  • as a single treatment for people who have been treated with one or more chemotherapy regimens for metastatic disease

Metastatic breast cancer is cancer that has spread to parts of the body away from the breast, such as the bones or liver.

Herceptin Hylecta side effects

Like Herceptin, Herceptin Hylecta can cause side effects, some of them severe. Common Herceptin Hylecta side effects include:

  • fatigue
  • joint pain
  • diarrhea
  • injection site reaction
  • upper respiratory tract infection
  • rash
  • muscle pain
  • nausea
  • headache
  • swelling
  • flushing
  • fever
  • cough
  • pain in extremities
  • chills
  • infection
  • heart problems
  • insomnia

Like Herceptin, less common but more severe side effects of Herceptin Hylecta include weakening of the heart muscle and other heart problems, as well as serious lung problems.

What this means for you

Because being treated with Herceptin Hylecta takes less time, it may be more convenient for you to receive an injection of Herceptin Hylecta than traditional IV Herceptin. If you’ve been diagnosed with HER2-positive breast cancer and Herceptin will be part of your treatment plan, you may want to ask your doctor if Herceptin Hylecta makes sense for your unique situation.

If you’re already being treated with traditional IV Herceptin, you may be able to switch to Herceptin Hylecta. You can ask your doctor if Herceptin Hylecta is an option for you.

“Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer,” says Sandra Horning, M.D., chief medical officer and head of global product development at Genentech, the maker of Herceptin Hylecta. “The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences.”

If your doctor prescribes Herceptin Hylecta and you face any difficulties getting it covered by insurance or you don't have insurance, you can get in touch with Access Solutions, sponsored by Genentech. Access Solutions can help investigate your insurance coverage benefits, appeal denied claims, and provide other assistance. You can also reach Access Solutions at 1-888-249-4918.

To talk with others diagnosed with HER2-positive breast cancer and making treatment decisions, join the Discussion Board forum on HER2+ (Positive) Breast Cancer.

Written by: Adam Leitenberger, editorial director

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

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