Difference between revisions of "Erdafitinib (Balversa)"
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(Created page with "==General information== Class/mechanism, from the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/erdafitinib NCI Drug Dictionary]: An orally bioavailable, p...") |
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==General information== | ==General information== | ||
| − | Class/mechanism | + | Class/mechanism: Tyrosine kinase inhibitor of 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. Erdafinitinib inhibits FGFR-related phosphorylation and signal transduction, resulting in inhibition and tumor cell death in FGFR-overexpressing tumor cells.<ref name="insert">[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/BALVERSA-pi.pdf Erdafitinib (Balversa) package insert]</ref><ref>[[Media:Erdafinitib.pdf| Erdafitinib (Balversa) package insert (locally hosted backup)]]</ref><ref>[https://www.balversa.com/ Balversa manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| − | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert. | + | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Bladder cancer]] | *[[Bladder cancer]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/BALVERSA-pi.pdf Erdafitinib (Balversa) package insert]<ref name="insert"></ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *4/12/2019: Accelerated approval for patients with locally advanced or metastatic [[Bladder_cancer|urothelial carcinoma]] | + | *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 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." |
==Also known as== | ==Also known as== | ||
Revision as of 18:35, 12 May 2019
General information
Class/mechanism: Tyrosine kinase inhibitor of 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. Erdafinitinib 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
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."
Also known as
- Code name: JNJ-42756493
- Brand name: Balversa