Puma Biotechnology Announces FDA Allowance to Proceed under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Puma Biotechnology, Inc. was notified by the US FDA that its investigational new drug application submission has been reviewed, and they can proceed with the clinical development of alisertib for the treatment of patients with human epidermal growth factor receptor 2-negative, hormone receptor-positive metastatic breast cancer in Puma’s Phase II ALISCA-Breast1 trial.