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- Puma Biotechnology (NASDAQ:PBYI) announced Wednesday that the U.S. FDA has greenlighted a Phase 2 trial to investigate its oral kinase inhibitor alisertib, in-licensed from Takeda (NYSE:TAK), in patients with breast cancer.
- The study named ALISCA-Breast1 is designed to evaluate alisertib in combination with endocrine therapy in patients with hormone receptor-positive, HER2-negative recurrent, or metastatic breast cancer who hadn’t undergone chemotherapy.
- According to the company’s Investigational New Drug Application (IND), the trial will be designed to evaluate the therapeutic combo as a late-line option for the patient group. Puma Biotechnology (PBYI) plans to start ALISCA-Breast1 in H2 2024.
- In September 2022, Takeda (TAK) outlicensed alisertib, an inhibitor of aurora kinase A, to PBYI in a deal worth $7M upfront and $287.3M in potential milestone payments.
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