Alisertib is under clinical development by Puma Biotechnology and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Alisertib’s likelihood of approval (LoA) and phase transition for Triple-Negative Breast Cancer (TNBC) took place on 26 Sep 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 26 Sep 2022 increased Alisertib’s Phase Transition Success Rate (PTSR) for Non-Small Cell Lung Cancer.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Alisertib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Alisertib overview

Alisertib (MLN-8237) is under development for the treatment of solid tumors including stage IV EGFR-mutated non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), recurrent and refractory central nervous system atypical teratoid rhabdoid tumors (ATRT), malignant pleural mesothelioma, triple negative breast cancer. It is a second-generation, orally bio-available, highly selective small molecule inhibitor of the serine/threonine protein kinase Aurora A kinase with potential anti-neoplastic activity. The drug candidate was under development for the treatment of Waldenstrom macroglobulinemia, high-grade glioma, Hodgkin's lymphoma, non-Hodgkin lymphoma including diffuse large B-cell lymphoma, B-cell lymphomas, relapsed or refractory transitional-cell carcinoma of the bladder and urothelial tract, relapsed or refractory peripheral T-cell lymphoma, precursor cell lymphoblastic leukemia-lymphoma, myelodysplastic syndrome, non-small cell lung cancer, gastroesophageal (GE) junction carcinomas, anaplastic astrocytoma, small-cell lung cancer, refractory or relapsed multiple myeloma, relapsed or refractory CD30-positive lymphomas such as Hodgkin's and anaplastic large cell lymphoma, squamous cell cancer of the head and neck, epithelial ovarian cancer, fallopian tube cancer, and relapsed and refractory B-cell chronic lymphocytic leukemia, relapsed/refractory neuroblastoma, neuroendocrine prostate cancer (NEPC) and hormone refractory (castration-resistant, androgen-independent) prostate cancer, peritoneal cancer, CD30-positive cancers such as testicular embryonal carcinoma, cutaneous angiosarcoma, nasopharyngeal non-keratinizing carcinoma and metastatic HPV associated cancers including cervical, vaginal, vulvar, penile, anal or oropharyngeal carcinoma and acute myelogenous leukemia.

Puma Biotechnology overview

Puma Biotechnology (Puma) is a biopharmaceutical company that develops novel therapeutics for the treatment of cancer. The company develops and commercializes drug candidates, namely, PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Its pipeline portfolio also encompasses investigational candidates for various indications such as adjuvant breast cancer, gastric cancer, metastatic breast cancer and HER2-positive breast cancer and other cancers. Puma in-licenses its drug candidates and advances its development through clinical testing and for commercial use. Puma manufacture and distribute its products through the third party contractors. Puma is headquartered in Los Angeles, California, the US.

Quick View Alisertib LOA Data

Report Segments
  • Innovator
Drug Name
  • Alisertib
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.