Difference between revisions of "Gefitinib (Iressa)"
Jump to navigation
Jump to search
m (→References) |
(FDA approval) |
||
| Line 1: | Line 1: | ||
==General information== | ==General information== | ||
| − | Class/mechanism: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Activating mutations of EGFR can drive tumor growth by activating pathways that promote proliferation, invasion, angiogenesis, metastasis, and inhibition of cell death. Gefitinib binds to the EGFR tyrosine kinase domain and inhibits these over-active signalling pathways. There are differences between specific EGFR mutations and their likelihood of clinical response to EGFR TKIs.<ref name="insert">[http://www.astrazeneca. | + | Class/mechanism: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Activating mutations of EGFR can drive tumor growth by activating pathways that promote proliferation, invasion, angiogenesis, metastasis, and inhibition of cell death. Gefitinib binds to the EGFR tyrosine kinase domain and inhibits these over-active signalling pathways. There are differences between specific EGFR mutations and their likelihood of clinical response to EGFR TKIs.<ref name="insert">[http://www.astrazeneca-us.com/cgi-bin/az_pi.cgi?product=iressa&country=us Gefitinib (Iressa) package insert]</ref><ref>[[Media:Gefitinib.pdf | Gefitinib (Iressa) package insert (locally hosted backup)]]</ref><ref>[https://www.iressa-usa.com Iressa 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 prescribing information.<ref name="insert"></ref> | 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 prescribing information.<ref name="insert"></ref> | ||
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Non-small cell lung cancer]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[http://chemocare.com/ | + | *[http://www.astrazeneca-us.com/cgi-bin/az_pi.cgi?product=iressa&country=us Gefitinib (Iressa) package insert]<ref name="insert"></ref> |
| + | *[http://chemocare.com/chemotherapy/drug-info/gefitinib.aspx Gefitinib (Iressa) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/gefitinib.aspx Gefitinib (Iressa) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/gefitinib-patient-drug-information Gefitinib (Iressa) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/gefitinib-patient-drug-information Gefitinib (Iressa) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/gefitinib-patient-drug-information Gefitinib (Iressa) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/gefitinib-patient-drug-information Gefitinib (Iressa) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *5/5/ | + | *5/5/2003: Granted accelerated FDA approval as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies. |
| − | *6/17/ | + | *6/17/2005: Due to the negative confirmatory trial, access of this drug was restricted to patients currently receiving and benefiting from Iressa; patients who have previously received and benefited from Iressa; and previously enrolled patients or new patients in non-Investigational New Drug (IND) clinical trials approved by an IRB prior to June 17, 2005. |
| + | *7/13/2015: [http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm454692.htm FDA approved] "for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations." | ||
==Also known as== | ==Also known as== | ||
| Line 27: | Line 32: | ||
[[Category:EGFR inhibitors]] | [[Category:EGFR inhibitors]] | ||
| − | [[Category: | + | [[Category:Non-small cell lung cancer medications]] |
| + | |||
[[Category:Drugs FDA approved in 2003]] | [[Category:Drugs FDA approved in 2003]] | ||
| + | [[Category:Drugs FDA approved in 2015]] | ||
Revision as of 03:48, 20 July 2015
General information
Class/mechanism: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Activating mutations of EGFR can drive tumor growth by activating pathways that promote proliferation, invasion, angiogenesis, metastasis, and inhibition of cell death. Gefitinib binds to the EGFR tyrosine kinase domain and inhibits these over-active signalling pathways. There are differences between specific EGFR mutations and their likelihood of clinical response to EGFR TKIs.[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 prescribing information.[1]
Diseases for which it is used
Patient drug information
- Gefitinib (Iressa) package insert[1]
- Gefitinib (Iressa) patient drug information (Chemocare)[4]
- Gefitinib (Iressa) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 5/5/2003: Granted accelerated FDA approval as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
- 6/17/2005: Due to the negative confirmatory trial, access of this drug was restricted to patients currently receiving and benefiting from Iressa; patients who have previously received and benefited from Iressa; and previously enrolled patients or new patients in non-Investigational New Drug (IND) clinical trials approved by an IRB prior to June 17, 2005.
- 7/13/2015: FDA approved "for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations."
Also known as
ZD1839