Ganitumab is under clinical development by Amgen and currently in the Phase II and Phase III 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 Ganitumab’s likelihood of approval (LoA) and phase transition for Childhood Rhabdomyosarcoma took place on 07 Dec 2020, 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.

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

Ganitumab overview

Ganitumab (AMG-479) is under development for the treatment of Ewing's sarcoma and rhabdomyosarcoma. It is administered intravenously. AMG-479 is a human monoclonal antibody against insulin-like growth factor 1 receptor (IGF-1R) and enhances the anti-neoplastic activity. It was also under development for advanced squamous non-small cell lung carcinoma, solid tumor, non-Hodgkin lymphoma, and metastatic breast cancer, small cell lung cancer, metastatic adenocarcinoma of the pancreas and metastatic pancreatic cancer, metastatic colorectal cancer and desmoplastic small round cell tumors, advanced carcinoid and neuroendocrine tumors, ovarian cancer and breast cancer.

Amgen overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.

Quick View Ganitumab LOA Data

Report Segments
  • Innovator
Drug Name
  • Ganitumab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

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.