Nerlynx Approved by FDA for HER2-positive Breast Cancer Patients to Reduce Risk of Recurrence

Nerlynx Approved by FDA for HER2-positive Breast Cancer Patients to Reduce Risk of Recurrence
The U.S. Food and Drug Administration (FDA) approved Puma Biotechnology's Nerlynx (neratinib) as an extended adjuvant treatment of early-stage, HER2-positive breast cancer. This means that Nerlynx is the first extended adjuvant therapy for patients suffering from this type of cancer. Adjuvant therapies are used as an addition to the primary treatment to help reach the ultimate goal, in this case to decrease even further the risk of cancer recurrence (when the cancer returns after treatment). The new adjuvant therapy was approved for adult patients who received previous treatment with the drug Herceptin (trastuzumab), a monoclonal antibody used to treat metastatic, HER2-positive breast cancer. "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," Richard Pazdur, MD, 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 a press release. "Now, these patients have an option after initial treatment that may help keep the cancer from coming back." Nerlynx works by blocking the action of several special proteins (enzymes) found to promote cells’ growth. The drug irreversibly binds to epidermal growth factor receptors (EGFRs), to human epidermal growth factor receptor 2 (HER2), and to HER4. The effectiveness and safety of Nerlynx was determined in the ongoing Phase 3 ExteNET trial (
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