Difference between revisions of "Lapatinib (Tykerb)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
* 3/13/2007: 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)''
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* 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)''
* 1/29/2010: 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)''
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* 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)''
**12/6/2018: Converted to regular approval.
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**2018-12-06: Converted to regular approval.
  
 
==History of changes in EMA indication==
 
==History of changes in EMA indication==
* 6/10/2008: Initial marketing authorization as Tyverb.
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* 2008-06-10: Initial marketing authorization as Tyverb.
  
 
==Also known as==
 
==Also known as==

Revision as of 11:44, 21 April 2023

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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2008-06-10: Initial marketing authorization as Tyverb.

Also known as

  • Code name: GW572016
  • Brand names: Abnib, Combinib, Etibo, Herduo, Herlapsa, Hertab, Lapanix, Lapatem, Tykerb, Tyverb

References