FDA Grants Neratinib Orphan Drug Status for Breast Cancer With Brain Metastases

Sep 3, 2019 – The FDA has granted an orphan drug designation to neratinib for the treatment of patients with breast cancer who have brain metastases. “Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer,” Alan H. Auerbach, chairman, chief executive officer and president of Puma Biotechnology, the developer of neratinib, in a press release. “Despite expanded … (leggi tutto)