Difference between revisions of "Lapatinib (Tykerb)"
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==General information== | ==General information== | ||
Class/mechanism: EGFR/HER2 tyrosine kinase inhibitor; 4-anilinoquinazoline inhibitor of the intracellular tyrosine kinase domains of EGFR (epidermal growth factor receptor/ErbB1) and HER2 (human epidermal growth factor receptor 2/ErbB2), which drive proliferation in certain malignancies. | Class/mechanism: EGFR/HER2 tyrosine kinase inhibitor; 4-anilinoquinazoline inhibitor of the intracellular tyrosine kinase domains of EGFR (epidermal growth factor receptor/ErbB1) and HER2 (human epidermal growth factor receptor 2/ErbB2), which drive proliferation in certain malignancies. | ||
| − | <ref name="insert">[ | + | <ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf Lapatinib (Tykerb) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/lapatinib.pdf Lapatinib (Tykerb) package insert (locally hosted backup)]</ref><ref>[http://www.tykerb.com/ Tykerb 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. | + | 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 or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | *[[Breast cancer, | + | *[[Breast cancer, HER2-positive|HER2+ breast cancer]] |
| + | *[[Colorectal cancer, HER2-positive|HER2+ colon cancer]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf#page=21 Lapatinib (Tykerb) patient drug information]<ref>[http://us.gsk.com/products/assets/us_tykerb.pdf#page=21 Lapatinib (Tykerb) patient drug information]</ref> |
*[http://chemocare.com/bio/lapitinib.asp Lapatinib (Tykerb) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/lapitinib.asp Lapatinib (Tykerb) patient drug information (Chemocare)]</ref> | *[http://chemocare.com/bio/lapitinib.asp Lapatinib (Tykerb) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/lapitinib.asp Lapatinib (Tykerb) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/lapatinib-patient-drug-information Lapatinib (Tykerb) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/lapatinib-patient-drug-information Lapatinib (Tykerb) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/lapatinib-patient-drug-information Lapatinib (Tykerb) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/lapatinib-patient-drug-information Lapatinib (Tykerb) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 2007-03-13: Initial approval in combination with [[Capecitabine (Xeloda) | capecitabine]], for the treatment of patients with advanced or metastatic [[breast cancer]] whose tumors [[Biomarkers#Overexpression|overexpress]] [[Biomarkers#HER2|HER2]] and who have received prior therapy including an [[:Category:Anthracyclines | anthracycline]], a [[:Category:Taxanes | taxane]], and [[Trastuzumab (Herceptin) | trastuzumab]]. ''(Based on EGF100151)'' |
| − | * | + | * 2010-01-29: Accelerated approval in combination with [[Letrozole (Femara) | letrozole]] for the treatment of postmenopausal women with [[Biomarkers#HR|hormone receptor]] [[Biomarkers#Expression|positive]] metastatic [[breast cancer]] that [[Biomarkers#Overexpression|overexpresses]] the [[Biomarkers#HER2|HER2 receptor]] for whom hormonal therapy is indicated. ''(Based on EGF30008)'' |
| + | **2018-12-06: Converted to regular approval. | ||
| + | ==History of changes in EMA indication== | ||
| + | * 2008-06-10: Initial marketing authorization as Tyverb. | ||
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *2009-05-15: Initial notice of compliance (unclear details) | ||
| + | *2010-09-30: New indication in combination with letrozole for the treatment of post-menopausal patients with hormone receptor positive metastatic [[breast cancer]], whose tumours over express the ErbB2 (HER2) receptor, and who are suitable for endocrine therapy. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2009-04-22: Initial approval for the treatment of inoperable or recurrent [[breast cancer]] with HER2 overexpression. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Brand | + | *'''Code name:''' GW-572016 |
| + | *'''Brand names:''' Abnib, Combinib, Etibo, Herduo, Herlapsa, Hertab, Lapanix, Lapatem, Tykerb, Tyverb | ||
==References== | ==References== | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
[[Category:Protein expression-specific medications]] | [[Category:Protein expression-specific medications]] | ||
| − | + | ||
[[Category:EGFR inhibitors]] | [[Category:EGFR inhibitors]] | ||
[[Category:ERBB2 inhibitors]] | [[Category:ERBB2 inhibitors]] | ||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
| + | [[Category:Colorectal cancer medications]] | ||
| − | [[Category: | + | [[Category:EMA approved in 2008]] |
| + | [[Category:FDA approved in 2007]] | ||
| + | [[Category:Health Canada approved in 2009]] | ||
| + | [[Category:PMDA approved in 2009]] | ||
Latest revision as of 01:02, 29 June 2024
General information
Class/mechanism: EGFR/HER2 tyrosine kinase inhibitor; 4-anilinoquinazoline inhibitor of the intracellular tyrosine kinase domains of EGFR (epidermal growth factor receptor/ErbB1) and HER2 (human epidermal growth factor receptor 2/ErbB2), which drive proliferation in certain malignancies.
[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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Lapatinib (Tykerb) patient drug information[4]
- Lapatinib (Tykerb) patient drug information (Chemocare)[5]
- Lapatinib (Tykerb) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 2007-03-13: Initial approval in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. (Based on EGF100151)
- 2010-01-29: Accelerated approval in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. (Based on EGF30008)
- 2018-12-06: Converted to regular approval.
History of changes in EMA indication
- 2008-06-10: Initial marketing authorization as Tyverb.
History of changes in Health Canada indication
- 2009-05-15: Initial notice of compliance (unclear details)
- 2010-09-30: New indication in combination with letrozole for the treatment of post-menopausal patients with hormone receptor positive metastatic breast cancer, whose tumours over express the ErbB2 (HER2) receptor, and who are suitable for endocrine therapy.
History of changes in PMDA indication
- 2009-04-22: Initial approval for the treatment of inoperable or recurrent breast cancer with HER2 overexpression.
Also known as
- Code name: GW-572016
- Brand names: Abnib, Combinib, Etibo, Herduo, Herlapsa, Hertab, Lapanix, Lapatem, Tykerb, Tyverb