Puma Biotechnology: FDA Allows To Proceed With Clinical Development Of Alisertib

(RTTNews) - Puma Biotechnology, Inc. (PBYI) said it has been notified by the FDA that its Investigational New Drug Application submission has been reviewed, and Puma 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-Breast trial. The trial will investigate alisertib in combination with endocrine treatment in chemotherapy-nave patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.

Puma plans to initiate the trial in the second half of 2024. The company said patients will be dosed with alisertib given at either 30 mg, 40 mg or 50 mg twice daily on days 1-3, 8-10 and 15-17 on a 28-day cycle in combination with the endocrine therapy of the investigator's choice. The primary efficacy end points will include objective response rate, duration of response, disease control rate and progression-free survival.

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