Erdafitinib is under clinical development by Johnson & Johnson 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 Erdafitinib’s likelihood of approval (LoA) and phase transition for Thyroid Cancer took place on 20 Dec 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 Erdafitinib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Erdafitinib overview

Erdafitinib (Balversa, Erfandel) is an alkyldiarylamine compound acts as an antineoplastic agent. It is formulated as film coated tablets for oral route of administration. Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Erdafitinib (JNJ-42756493) is under development for the treatment of metastatic or surgically unresectable urothelial cancer (second line therapy), high-grade glioma, duodenal cancer, thyroid cancer, salivary gland cancer, endometrial cancer, colorectal cancer, pancreatic cancer, refractory solid tumors and lymphomas including squamous and non-squamous non-small cell lung cancer, relapsed/ refractory multiple myeloma, small cell lung cancer, advanced hepatocellular carcinoma (HCC), breast cancer, ovarian cancer, prostate cancer, lung adenocarcinoma, head and neck cancer, esophageal cancer, cholangiocarcinoma, non muscle invasive bladder cancer (NMIBC), muscle invasive bladder cancer (MIBC), glioblastoma multiforme and gastric cancer. The drug candidate is administered orally. It is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor and is based on fragment-based pyramid platform. It is a new molecular entity (NME).

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular and metabolic diseases; consumer products in oral care, baby care, beauty, over-the-counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). J&J is headquartered in New Brunswick, New Jersey, the US.

Quick View Erdafitinib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Erdafitinib
Administration Pathway
  • Intravesical
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Johnson & Johnson
  • Originator: Janssen Pharmaceutica and Astex Pharmaceuticals
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.