Bemarituzumab is under clinical development by Amgen and currently in the Phase I, 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 Bemarituzumab’s likelihood of approval (LoA) and phase transition for Colorectal Cancer took place on 24 Nov 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 24 Nov 2022 decreased Bemarituzumab’s LoA and PTSR for Esophageal Squamous Cell Carcinoma (ESCC), and decreased PTSR for Pancreatic Ductal Adenocarcinoma.

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

Bemarituzumab overview

Bemarituzumab [FPA-144] is under development for the treatment of solid tumors such as gastric cancer, gastroesophageal cancer, transitional cell carcinoma, lymphoma, bladder cancer, head and neck squamous cell carcinoma, lung adenocarcinoma, fallopian tube cancer, peritoneal cancer, esophageal squamous cell carcinoma, triple-negative breast cancer, pancreatic ductal adenocarcinoma, intrahepatic cholangiocarcinoma, colorectal adenocarcinoma, ovarian epithelial cell carcinoma, endometrial adenocarcinoma and cervical carcinoma. The drug candidate is administered through intravenous route. It is a humanized monoclonal antibody directed against a splice form of fibroblast growth factor receptor 2 (FGFR2). It is a targeted immunotherapy for FGFR2b-overexpressing tumors and designed to recruit tumor-killing NK cells into the tumor microenvironment. The drug candidate is developed based on Potelligent CHOK1SV technology. Potelligent CHOK1SV, combines the advantages of GS Gene Expression System with the glyco-engineered technology.

It was also under development for the treatment of 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 Bemarituzumab LOA Data

Report Segments
  • Innovator
Drug Name
  • Bemarituzumab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Amgen
  • Originator: Galaxy Biotech
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.