Difference between revisions of "Olaratumab (Lartruvo)"
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Warner-admin (talk | contribs) m (Text replacement - "manufacturer. Instead" to "manufacturer. Instead") |
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| + | '''Note: as of April 2019, the manufacturer has decided to discontinue the product after the confirmatory RCT was negative.''' | ||
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=General information= | =General information= | ||
| − | Class/mechanism: Human IgG1 antibody that blocks the activity of platelet-derived growth factor receptor alpha (PDGFR-α). Olaratumab prevents binding of PDGF-AA and -BB ligands to PDGFR-α and blocks PDGF-AA, -BB, and -CC-induced receptor activation and downstream PDGFR-α pathway signaling, including the MAPK and PI3K pathways. PDGFR-α is a receptor tyrosine kinase expressed on mesenchymal origin cells, and signaling through PDGFR-α is involved in cell growth, chemotaxis, and mesenchymal stem cell differentiation.<ref name="insert">[http://pi.lilly.com/us/lartruvo-uspi.pdf Olaratumab (Lartruvo) package insert]</ref><ref>[[ | + | Class/mechanism: Human IgG1 antibody that blocks the activity of platelet-derived growth factor receptor alpha (PDGFR-α). Olaratumab prevents binding of PDGF-AA and -BB ligands to PDGFR-α and blocks PDGF-AA, -BB, and -CC-induced receptor activation and downstream PDGFR-α pathway signaling, including the MAPK and PI3K pathways. PDGFR-α is a receptor tyrosine kinase expressed on mesenchymal origin cells, and signaling through PDGFR-α is involved in cell growth, chemotaxis, and mesenchymal stem cell differentiation.<ref name="insert">[http://pi.lilly.com/us/lartruvo-uspi.pdf Olaratumab (Lartruvo) package insert]</ref><ref>[[:File:Olaratumab.pdf | Olaratumab (Lartruvo) package insert (locally hosted backup)]]</ref><ref>[http://lartruvo.com/ Lartruvo manufacturer's website]</ref><ref>[https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=626630 NCI Drug Dictionary entry for olaratumab]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
| Line 6: | Line 8: | ||
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 | + | ==Diseases for which it was used== |
| − | *[[ | + | *[[Soft tissue sarcoma]] |
==Patient drug information== | ==Patient drug information== | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10 | + | ===[[Soft tissue sarcoma]] - '''WITHDRAWN'''=== |
| + | *2016-10-19: Accelerated approval for the treatment of patients with [[Soft tissue sarcoma|soft tissue sarcoma (STS)]] not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. ''(Based on CP15-0806)'' | ||
| + | **2020-02-25: Accelerated approval withdrawn. ''(Based on ANNOUNCE)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2016-11-09: Initial authorization as Lartruvo. Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced [[soft tissue sarcoma]] who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin. | ||
| + | *2019-04-26: Approval withdrawn. ''(Based on ANNOUNCE)'' | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2017-11-23: Initial notice of compliance with conditions | ||
| + | *2020-10-08: Approval withdrawn. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code names:''' | + | *'''Code names:''' LY-3012207, IMC-3G3 |
*'''Brand name:''' Lartruvo | *'''Brand name:''' Lartruvo | ||
| Line 22: | Line 32: | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | |||
[[Category:Anti-PDGFR antibodies]] | [[Category:Anti-PDGFR antibodies]] | ||
| − | [[Category: | + | [[Category:Soft tissue sarcoma medications (historic)]] |
| − | [[Category: | + | [[Category:FDA approved in 2016]] |
| − | [[Category: | + | [[Category:EMA approved in 2016]] |
| + | [[Category:Health Canada approved in 2017]] | ||
| + | |||
| + | [[Category:Discontinued drugs]] | ||
| + | [[Category:EMA withdrawn in 2019]] | ||
| + | [[Category:FDA withdrawn in 2020]] | ||
| + | [[Category:Health Canada withdrawn in 2020]] | ||
Latest revision as of 11:43, 9 April 2024
Note: as of April 2019, the manufacturer has decided to discontinue the product after the confirmatory RCT was negative.
General information
Class/mechanism: Human IgG1 antibody that blocks the activity of platelet-derived growth factor receptor alpha (PDGFR-α). Olaratumab prevents binding of PDGF-AA and -BB ligands to PDGFR-α and blocks PDGF-AA, -BB, and -CC-induced receptor activation and downstream PDGFR-α pathway signaling, including the MAPK and PI3K pathways. PDGFR-α is a receptor tyrosine kinase expressed on mesenchymal origin cells, and signaling through PDGFR-α is involved in cell growth, chemotaxis, and mesenchymal stem cell differentiation.[1][2][3][4]
Route: IV
Extravasation: no information
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 was used
Patient drug information
- Brief patient counseling information can be found in the Olaratumab (Lartruvo) package insert [1]
History of changes in FDA indication
Soft tissue sarcoma - WITHDRAWN
- 2016-10-19: Accelerated approval for the treatment of patients with soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. (Based on CP15-0806)
- 2020-02-25: Accelerated approval withdrawn. (Based on ANNOUNCE)
History of changes in EMA indication
- 2016-11-09: Initial authorization as Lartruvo. Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin.
- 2019-04-26: Approval withdrawn. (Based on ANNOUNCE)
History of changes in Health Canada indication
- 2017-11-23: Initial notice of compliance with conditions
- 2020-10-08: Approval withdrawn.
Also known as
- Code names: LY-3012207, IMC-3G3
- Brand name: Lartruvo