FX.co ★ Puma Biotechnology: FDA Allows To Proceed With Clinical Development Of Alisertib

Puma Biotechnology, Inc. has recently announced that its New Drug Investigation Application for alisertib is now approved by the FDA. The company can proceed with the clinical development of this drug in its Phase II ALISCA-Breast trial, aiming to treat patients with hormone receptor-positive, HER2-negative metastatic breast cancer.

The trial will explore the potential of alisertib used along with endocrine treatment. This combined therapeutic approach will be tested on chemotherapy-naive patients suffering from recurrent or metastatic breast cancer that is hormone receptor-positive and HER2-negative.

Puma Biotechnology is set to launch the trial in the latter part of 2024. Patients involved in the trial will receive alisertib dosages of either 30 mg, 40 mg, or 50 mg twice daily. This will take place on days 1-3, 8-10, and 15-17 of a 28-day cycle, utilized in combination with an endocrine therapy chosen by the investigator.

The efficacy of the therapy will largely depend on factors such as the objective response rate, duration of the response, disease control rate, and progression-free survival.

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