Difference between revisions of "Gefitinib (Iressa)"
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*5/5/03: 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. | *5/5/03: 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. | ||
*6/17/05: 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. | *6/17/05: 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. | ||
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| + | ==Also known as== | ||
| + | ZD1839 | ||
==References== | ==References== | ||
Revision as of 00:01, 16 December 2014
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]
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]
Patient drug information
- Gefitinib (Iressa) patient drug information (Chemocare)[3]
- Gefitinib (Iressa) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 5/5/03: 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.
- 6/17/05: 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.
Also known as
ZD1839