Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Erdafitinib
Drug ID BADD_D02506
Description In early April of 2019, the US FDA approved Janssen Pharmaceutical Companies' brand name Balversa (erdafitinib) as the first-ever fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy [L5956, L5959]. At the same time, the FDA also approved the therascreen FGFR RGQ RT-PCR Kit (Qiagen) for utilization as a companion diagnostic with erdafitinib for selecting patients for the indicated therapy [L5956, L5959]. Erdafitinib's innovation lies in the fact that it is the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer, which demonstrates the design of erdafitinib in developing more personalized and precision medicines with the capacity to target cancer treatment to a patient's specific genetic mutation [L5956, L5959]. Considering urothelial cancer is statistically the fourth most common kind of cancer in the world [F4372], the introduction of erdafitinib offers a welcome new option in the ever-expanding therapeutic tool kit to treat such prevalent medical conditions. Nevertheless, although erdafitinib was granted Breakthrough Therapy designation and Accelerated Approval from the FDA so as to allow the agency to focus on and expedite the approval process for a medication indicated for a serious condition that fills an unmet medical need using clinical trial data that is believed to predict a genuine clinical benefit for patients with the given condition, such designations mean further ongoing clinical trials are necessary to confirm the clinical benefit of erdafitinib going forward [L5956, L5959].
Indications and Usage Not Available
Marketing Status Not Available
ATC Code L01EN01
DrugBank ID DB12147
KEGG ID D10927
MeSH ID C000604580
PubChem ID 67462786
NDC Product Code 59676-030; 59676-040; 59676-050
Synonyms erdafitinib | JNJ-42756493 | Balversa
Chemical Information
Molecular Formula C25H30N6O2
CAS Registry Number 1346242-81-6
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Eye disorder06.08.03.0010.001066%Not Available
Hepatitis09.01.07.0040.000533%Not Available
Mucosal inflammation08.01.06.0020.000533%Not Available
Onycholysis23.02.05.0040.000533%Not Available
Visual impairment06.02.06.0080.000533%Not Available
Blood phosphorus increased13.11.01.0160.000799%Not Available
Disease progression08.01.03.0380.000347%
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