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FDA Approves Talzenna to Treat Metastatic Breast Cancer in Women With BRCA Mutations

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On Oct. 16, 2018, the U.S. Food and Drug Administration (FDA) approved Talzenna (chemical name: talazoparib) to treat locally advanced or metastatic HER2-negative breast cancer in women with an inherited BRCA1 or BRCA2 mutation.

Read the FDA announcement about Talzenna.

Locally advanced 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.

Most inherited cases of breast cancer are associated with two abnormal genes: BRCA1 (BReast CAncer gene one) and BRCA2 (BReast CAncer gene two). Women with a mutation in the BRCA1 or BRCA2 gene have up to an 72% risk of developing breast cancer by age 80. Their risk of ovarian cancer also is higher than average. Men with an abnormal BRCA gene have a higher risk of both breast and prostate cancer.

DNA carries genetic information in both healthy cells and cancer cells. Cells can develop DNA damage spontaneously or from exposure to specific things in the environment (too much sun, for example) that make DNA damage more likely to happen. But cells can detect and repair damage to DNA. When DNA is damaged in a healthy cell and the damage isn't fixed, that cell can become cancerous. Mutated BRCA1 and BRCA2 genes are thought to increase the risk of breast and other cancers because these abnormal genes interfere with cells’ ability to repair damaged DNA.

The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy and cancer cells. Research has shown that Talzenna, which interferes with (inhibits) the PARP enzyme, makes it even harder for cancer cells with an abnormal BRCA1 or BRCA2 gene to fix DNA damage. This makes it harder for the cancer cells to survive. In other words, a PARP inhibitor makes some cancer cells less likely to survive their DNA damage.

About Talzenna

Talzenna is a pill taken by mouth.

Talzenna is the second PARP inhibitor approved to treat breast cancer. Lynparza (chemical name: olaparib) is also a PARP inhibitor.

The FDA’s approval of Talzenna to treat certain BRCA-mutation-linked breast cancers is based on results from the EMBRACA trial showing that Talzenna improved progression-free survival by about 3 months compared to standard chemotherapy in women diagnosed with metastatic, HER2-negative breast cancer with a BRCA1 or BRCA2 mutation.

Progression-free survival is how long a woman lives without the cancer growing.

Like almost all cancer medicines, Talzenna can cause side effects, some of them severe.

Common side effects of Talzenna include:

  • anemia (low red blood cell counts)
  • hair loss
  • neutropenia (low white blood cell counts)
  • thrombocytopenia (low platelet counts)
  • loss of appetite
  • headache
  • nausea
  • vomiting
  • diarrhea
  • fatigue

Severe but less common side effects of Talzenna include:

  • developing certain blood or bone marrow cancers

"The [EMBRACA] trial found that talazoparib provides a significant clinical benefit to all patient subgroups, including those with hormone-receptor-positive and triple-negative disease," said lead researcher Jennifer Litton, M.D., associate professor of breast medical oncology at the University of Texas MD Anderson Cancer Center, in an interview with in December 2017. "The results of this trial are quite exciting and indicate talazoparib is a novel treatment option for patients with metastatic breast cancer and BRCA mutations."

If you’ve been diagnosed with locally advanced or metastatic HER2-negative breast cancer and know you have a BRCA1 or BRCA2 mutation, you may want to talk to your doctor about Talzenna to ask whether it makes sense for your unique situation. If you have been diagnosed with locally advanced or metastatic HER2-negative breast cancer and have not had genetic testing, it’s a good idea to ask your doctor about it to see if Talzenna or Lynparza would make sense for your unique situation.

To talk with others who have been diagnosed with advanced disease, join the Discussion Board forum Stage IV and Metastatic Breast Cancer ONLY.

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