Difference between revisions of "Erdafitinib (Balversa)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *4/12/2019: [https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-metastatic-bladder-cancer Accelerated FDA approval] for adult patients with locally advanced or metastatic [[Bladder_cancer|urothelial carcinoma]] that has susceptible [[Biomarkers#FGFR3|FGFR3]] or [[Biomarkers#FGFR2|FGFR2]] [[Biomarkers#Alterations|genetic alterations]] and progressed during or following at least one line of prior [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]] including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. | + | *4/12/2019: [https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-metastatic-bladder-cancer Accelerated FDA approval] for adult patients with locally advanced or metastatic [[Bladder_cancer|urothelial carcinoma]] that has susceptible [[Biomarkers#FGFR3|FGFR3]] or [[Biomarkers#FGFR2|FGFR2]] [[Biomarkers#Alterations|genetic alterations]] and progressed during or following at least one line of prior [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]] including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. ''(Based on BLC2001)'' |
==Also known as== | ==Also known as== | ||
Revision as of 00:28, 4 May 2021
General information
Class/mechanism: Tyrosine kinase inhibitor. Erdafitinib inhibits multiple receptor tyrosine kinases (RTKs), including fibroblast growth factor receptors (FGFR) FGFR1, FGFR2, FGFR3, FGFR4, as well as RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT, and VEGFR2. Erdafitinib inhibits FGFR-related phosphorylation and signal transduction, resulting in inhibition and tumor cell death in FGFR-overexpressing tumor cells.[1][2][3]
Route: PO
Extravasation: n/a
- Monitor for hyperphosphatemia; dose adjustments may be needed per package insert[1]
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the package insert.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 4/12/2019: Accelerated FDA approval for adult patients with locally advanced or metastatic urothelial carcinoma 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. (Based on BLC2001)
Also known as
- Code name: JNJ-42756493
- Brand name: Balversa
- Synonym: Erda