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Home » FDA Approves Nerlynx-Capecitabine Combination for Breast Cancer
FDA Approves Nerlynx-Capecitabine Combination for Breast Cancer
The FDA has given the greenlight for Puma Biotechnology’s Nerlynx (neratinib) in combination with capecitabine for adults with advanced or metastatic HER2-positive breast cancer.
The agency’s approval is for patients who have received two or more prior anti-HER2 based regimens in the metastatic setting. Nerlynx received a fast track designation and the approval was granted two months ahead of schedule.
The drug is also approved for extended adjuvant treatment of adults with early stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy.
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