Cetuximab sarotalocan is under clinical development by Rakuten Medical 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 Cetuximab sarotalocan’s likelihood of approval (LoA) and phase transition for Recurrent Head And Neck Cancer Squamous Cell Carcinoma took place on 20 Jan 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Cetuximab sarotalocan overview

Cetuximab sarotalocan (Akalux) is a chimeric monoclonal antibody (IgG1), acts as anti-neoplastic agent. It is formulated as solution for intravenous drip route of administration. Akalux is indicated for the treatment of unresectable locally advanced or locally recurrent head and neck cancer. RM-1929 is under development for the treatment of squamous cell esophageal cancer, cutaneous squamous cell carcinoma, recurrent head and neck cancer, gastric cancer and unspecified cancer. It is administered as an intravenous infusion. The drug candidate is a chemical conjugate of phthalocyanine dye IRDye 700DX with cetuximab. It targets EGFR. It is based on Illuminox technology platform.

Rakuten Medical overview

Rakuten Medical is a clinical-stage biotechnology company that develops first-in-class precision-targeted cancer drugs for the treatment of solid tumors. The company harnesses the Photoimmunotherapy (PIT) platform to develop its products. It’s lead pipeline product candidate, RM-1929, an antibody conjugate of cetuximab and IRDye 700DX, targets epidermal growth factor receptors (EGFR), which find expression in various types of solid tumors, including cancers of the head and neck, colon, esophagus, lung, pancreas and others. This first-in-class treatment harnesses an antibody conjugate to accurately act against cancer cells by activating the conjugated dye with red light to draw quick anti-cancer responses. Rakuten Medical is headquartered in San Mateo, California, the US.

Quick View Cetuximab sarotalocan LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Cetuximab sarotalocan
Administration Pathway
  • Intravenous
  • Intravenous Drip
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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.