Halaven Approved by FDA to Treat Metastatic Breast Cancer

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The U.S. Food and Drug Administration (FDA) has approved a new chemotherapy medicine, Halaven (chemical name: eribulin), to treat metastatic breast cancer that already has been treated with other chemotherapy medicines.

Metastatic breast cancer is advanced-stage cancer that has spread to parts of the body away from the breast -- the bones, liver, or brain for example. Halaven is recommended to be used only after metastatic breast cancer has been treated with two standard types of chemotherapy medicines: an anthracycline and a taxane. Adriamycin (chemical name: doxorubicin) and Ellence (chemical name: epirubicin) are anthracyclines. Taxol (chemical name: paclitaxel), Taxotere (chemical name: docetaxel), and Abraxane (chemical name: albumin-bound or nab-paclitaxel) are taxanes.

Halaven is made from a sea sponge. Like some other chemotherapy medicines, Halaven works by interfering with microtubulin, a component of cells. When both healthy and cancer cells divide, microtubulin acts as a building block for the structures that make sure the cell reproduces. Microtubulin also helps sort genetic material in the cell during cell division. So interfering with microtubulin can disrupt cell division and make cancer cells die. Halaven is classified as a microtubule inhibitor.

The FDA approval of Halaven was based on results from the EMBRACE study. This study found that Halaven could be a good treatment option for metastatic breast cancer that had stopped responding or failed to respond to other treatments. Compared to women who got a standard treatment for metastatic breast cancer or supportive care, women treated with Halaven:

  • were more likely to respond to treatment
  • lived longer without the cancer growing
  • lived longer overall

Better overall survival is important because several other new treatments for metastatic breast cancer have improved the length of time before the cancer starts growing again, but not overall survival.

The EMBRACE study also found that Halaven could be effective against metastatic breast cancers with a variety of characteristics:

  • hormone-receptor-positive or hormone-receptor-negative
  • HER2-positive or HER2-negative
  • in one or more than one location away from the breast
  • in the liver, lung, brain, bones
  • previously treated or not with the chemotherapy medicine Xeloda (chemical name: capecitabine)

The side effects of Halaven are similar to the side effects of other chemotherapy medicines, including hair loss, neuropathy (tingling or numbness in the hands and feet), low white blood cell counts, and fever. In the EMBRACE study, about 25% of women who got Halaven had to lower their dosage or stop treatment because of serious side effects or complications.

If you're being treated for advanced-stage breast cancer, you and your doctor may be considering a number of treatment options, especially if the cancer has stopped responding to standard treatments. You may want to ask your doctor about Halaven and whether it might be a good treatment option for you based on your unique situation.

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