A new drug to reduce the risk of breast cancer recurrence was approved by the U.S. Food and Drug Administration.
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The drug Nerlynx (neratinib) was approved for extended adjuvant treatment of early-stage, HER2-positive breast cancer. Extended adjuvant therapy is given after initial treatment to further reduce the risk that cancer will return.
Nerlynx, from Puma Biotechnology Inc., is the first extended adjuvant therapy for patients with early-stage, HER2-positive breast cancer and is for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.
"HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan. Now, these patients have an option after initial treatment that may help keep the cancer from coming back," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
The approval is based on a study of more than 2,800 patients who had completed treatment with trastuzumab (Herceptin) within the previous two years. After two years, 94.2 percent of patients treated with Nerlynx did not have cancer recurrence or death, compared with 91.9 percent of patients who received a placebo.
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