Difference between revisions of "Lorlatinib (Lorbrena)"
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m (Jwarner moved page Lorlatinib (PF-06463922) to Lorlatinib (Lorbrena): FDA approval) |
Warner-admin (talk | contribs) m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information") |
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<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 | + | 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. |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 11: | Line 11: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 11 | + | * 2018-11-02: Granted accelerated approval for patients with [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. ''(Based on B7461001)'' |
| + | ** 2021-03-03: Granted regular approval for patients with metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] whose tumors are [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]]. ''(Converted to regular approval; prior therapy requirement removed; based on CROWN)'' | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2019-05-06: Initial conditional approval as Lorviqua | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2019-02-22: Initial notice of compliance with conditions | ||
| + | *2022-05-20: Conditions were met | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2018-09-21: Conditional new approval for the treatment of unresectable or recurrent anaplastic lymphoma kinase (ALK)-positive [[non-small cell lung cancer]] with resistance or intolerance to ALK tyrosine kinase inhibitors. | ||
| + | *2021-11-25: New indication for the treatment of unresectable or advanced/recurrent anaplastic lymphoma kinase (ALK) fusion gene-positive [[non-small cell lung cancer]]. | ||
| + | ==Patient Drug Information== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf Lorlatinib (Lorbrena) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf Lorlatinib (Lorbrena) Package Insert]</ref> | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' PF-06463922 | *'''Code name:''' PF-06463922 | ||
| − | *'''Brand name:''' Lorbrena | + | *'''Brand name:''' Lorbrena, Lorviqua |
| + | |||
| + | ==References== | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| + | [[Category:Mutation-specific medications]] | ||
| − | |||
[[Category:ALK inhibitors]] | [[Category:ALK inhibitors]] | ||
[[Category:ROS1 inhibitors]] | [[Category:ROS1 inhibitors]] | ||
| Line 27: | Line 41: | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2019]] | ||
| + | [[Category:Health Canada approved in 2019]] | ||
| + | [[Category:PMDA approved in 2018]] | ||
Latest revision as of 00:59, 29 June 2024
General information
Class/mechanism, from the NCI Drug Dictionary: An orally available, ATP-competitive inhibitor of the receptor tyrosine kinases, anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (Ros1), with potential antineoplastic activity. Upon administration, lorlatinib binds to and inhibits both ALK and ROS1 kinases. The kinase inhibition leads to disruption of ALK- and ROS1-mediated signaling and eventually inhibits tumor cell growth in ALK- and ROS1-overexpressing tumor cells. In addition, lorlatinib is able to cross the blood brain barrier.
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.
Diseases for which it is used
History of changes in FDA indication
- 2018-11-02: Granted accelerated approval for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. (Based on B7461001)
- 2021-03-03: Granted regular approval for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. (Converted to regular approval; prior therapy requirement removed; based on CROWN)
History of changes in EMA indication
- 2019-05-06: Initial conditional approval as Lorviqua
History of changes in Health Canada indication
- 2019-02-22: Initial notice of compliance with conditions
- 2022-05-20: Conditions were met
History of changes in PMDA indication
- 2018-09-21: Conditional new approval for the treatment of unresectable or recurrent anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with resistance or intolerance to ALK tyrosine kinase inhibitors.
- 2021-11-25: New indication for the treatment of unresectable or advanced/recurrent anaplastic lymphoma kinase (ALK) fusion gene-positive non-small cell lung cancer.
Patient Drug Information
Also known as
- Code name: PF-06463922
- Brand name: Lorbrena, Lorviqua