Erdafitinib is under clinical development by Johnson & Johnson and currently in Phase II for Low-Grade Glioma. According to GlobalData, Phase II drugs for Low-Grade Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Erdafitinib LoA Report. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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, neurovascular care, 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.

For a complete picture of Erdafitinib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.