FDA Approves Nerlynx-Capecitabine Combo for HER2-positive Metastatic Breast Cancer

FDA Approves Nerlynx-Capecitabine Combo for HER2-positive Metastatic Breast Cancer
Nerlynx (neratinib) is now approved in the U.S. for use, in combination with capecitabine, to treat HER2-positive breast cancer patients who have received two or more HER2-targeted therapies for their metastatic disease, Nerlynx maker Puma Biotechnology said. Recommended doses are 240 mg of Nerlynx (six tablets) once daily plus capecitabine (750 mg/m2 given orally twice daily) for the first two weeks of each three-week cycle, until disease progression or unacceptable toxicity. Puma's request to extend Nerlynx's label was accepted by the U.S. Food and Drug Administration (FDA) on the basis of positive results of the NALA Phase 3 trial (NCT01808573). That trial found that the combination prolonged the lives of patients without disease worsening, as compared with Novartis‘ Tykerb (
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