Our Mission

Puma Biotechnology is a biopharmaceutical company dedicated to the acquisition, development, and commercialization of novel therapeutics for the treatment of cancer.

Clinical Trials

ALISCA™: ALISertib in CAncer

Alisertib

Alisertib (also known as PB-8237 or MLN8237) is an investigational oral drug that is a highly selective Aurora kinase A inhibitor. Alisertib targets Aurora kinase A, which is involved in cell division and can contribute to the growth of cancer cells. Currently, alisertib is being developed for the treatment of hormone receptor positive (HR+), human epidural growth factor receptor 2 negative (HER2-) metastatic breast cancer and small cell lung cancer.

Proposed Mechanism of Action (MOA):

  • Alisertib has shown to selectively bind to and inhibit Aurora kinase A.
  • Inhibition of Aurora kinase A disrupts mitotic spindle apparatus assembly, chromosome segregation, and cell proliferation.
  • This can lead to cell death.
The precise MOA of alisertib is unknown. Description is not intended to convey attributes of clinical efficacy or safety.

Clinical Investigation:

  • Alisertib is being investigated in combination with endocrine therapies as a potential treatment for hormone receptor positive (HR+), human epidural growth factor receptor 2 negative (HER2-) metastatic breast cancer following progression on or after two lines of endocrine therapy in the recurrent or metastatic setting.
  • Alisertib is being investigated as a potential treatment for small cell lung cancer after progression following first-line chemotherapy and immunotherapy.
  • The FDA has granted orphan drug designation to alisertib for small cell lung cancer.
Alisertib is an investigational drug and it has not been approved by any health authority. Safety and efficacy of alisertib have not been established.

Oncology Education Corner

Navigating cancer may feel overwhelming at times, especially when faced with difficult medical terms, treatment options, and trying to cope with cancer. This page was created as part of our Cancer Education Program to provide clear, easy-to-understand information for people with breast and lung cancers.

Whether you're curious about what a clinical trial is, looking for tips to help manage side effects, or exploring ways to take care of your overall well-being, our goal is to help you feel more informed and supported. While this information is not medical advice, we hope it gives you helpful tools and questions to bring to your healthcare team which is your best source for guidance about your treatment.



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