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.