Difference between revisions of "Avelumab (Bavencio)"
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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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==General information== | ==General information== | ||
| − | Class/mechanism: PD-L1 blocking antibody. PD-L1 (programmed death-1 ligand 1) expressed on tumor cells and tumor-infiltrating immune cells can result in inhibition of anti-tumor immune responses. | + | Class/mechanism: PD-L1 blocking antibody. PD-L1 (programmed death-1 ligand 1) expressed on tumor cells and tumor-infiltrating immune cells can result in inhibition of anti-tumor immune responses. Avelumab binds to PD-1 and B7.1 receptors on T-cells and antigen presenting cells and prevents PD-L1's inhibitory effects on the immune system. As a result, avelumab stimulates immune responses, including anti-tumor immune effects.<ref name=insert>[https://www.emdserono.com/us-en/pi/bavencio-pi.pdf Avelumab (Bavencio) package insert]</ref><ref>[[:File:Avelumab.pdf | Avelumab (Bavencio) package insert (locally hosted backup)]]</ref><ref>[http://www.bavencio.com Bavencio manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>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 | + | 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> |
==Toxicity management== | ==Toxicity management== | ||
| Line 10: | Line 10: | ||
==Diseases for which it is established== | ==Diseases for which it is established== | ||
| − | |||
*[[Merkel cell carcinoma]] | *[[Merkel cell carcinoma]] | ||
| − | *[[ | + | *[[Clear cell renal cell carcinoma]] |
| + | *[[Urothelial carcinoma]] | ||
==Patient drug information== | ==Patient drug information== | ||
*[https://www.emdserono.com/us-en/pi/bavencio-pi.pdf Avelumab (Bavencio) package insert]<ref name="insert"></ref> | *[https://www.emdserono.com/us-en/pi/bavencio-pi.pdf Avelumab (Bavencio) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/avelumab.aspx Avelumab (Bavencio) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/avelumab.aspx Avelumab (Bavencio) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/avelumab-patient-drug-information Avelumab (Bavencio) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/avelumab-patient-drug-information Avelumab (Bavencio) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/avelumab-patient-drug-information Avelumab (Bavencio) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/avelumab-patient-drug-information Avelumab (Bavencio) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | |||
| − | |||
| − | |||
| − | |||
===[[Merkel cell carcinoma]]=== | ===[[Merkel cell carcinoma]]=== | ||
| − | * | + | *2017-03-23: Initial [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm547965.htm accelerated approval] for the treatment of patients 12 years and older with metastatic [[Merkel cell carcinoma|Merkel cell carcinoma (MCC)]]. ''(Based on JAVELIN Merkel 200)'' |
===[[Renal cell carcinoma]]=== | ===[[Renal cell carcinoma]]=== | ||
| − | * | + | *2019-05-14: Approved in combination with [[Axitinib (Inlyta)|axitinib]] for first-line treatment of patients with advanced [[Renal cell carcinoma|renal cell carcinoma (RCC)]]. ''(Based on JAVELIN Renal 101)'' |
| + | ===[[Urothelial carcinoma]]=== | ||
| + | *2017-05-09: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm557162.htm Granted accelerated approval] for patients with locally advanced or metastatic [[urothelial carcinoma]] whose disease progressed during or following [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]] or within 12 months of neoadjuvant or adjuvant [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]]. ''(Based on JAVELIN Solid Tumor)'' | ||
| + | **2020-06-30: Full approval for maintenance treatment of patients with locally advanced or metastatic [[urothelial carcinoma|urothelial carcinoma (UC)]] that has not progressed with first-line platinum-containing chemotherapy. ''(Converted to regular approval; expanded to maintenance setting; based on JAVELIN Bladder 100)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2017-09-18: Initial marketing authorization as Bavencio. Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic [[Merkel cell carcinoma|Merkel cell carcinoma (MCC)]]. ''(Based on JAVELIN Merkel 200)'' | ||
| + | *2019-10-24: Extension of indication to include first-line combination treatment with avelumab and axitinib in adult patients with advanced [[renal cell carcinoma]] (aRCC). | ||
| + | *2021-01-21: Extension of indication to include a new indication for Bavencio in the treatment as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic [[urothelial carcinoma|urothelial carcinoma (UC)]] who are progression-free following platinum based chemotherapy. | ||
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *2017-12-18: Initial notice of compliance with conditions for the treatment of metastatic [[Merkel cell carcinoma|Merkel Cell Carcinoma (MCC)]] in previously treated adults. | ||
| + | **2021-01-13: Conditions were met for the treatment of metastatic [[Merkel cell carcinoma|Merkel Cell Carcinoma (MCC)]] in previously treated adults. | ||
| + | *2018-05-04: Notice of compliance with conditions for the treatment of patients with locally advanced or metastatic [[urothelial carcinoma]] who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. | ||
| + | **2019-05-14: Conditions were met for the treatment of patients with locally advanced or metastatic [[urothelial carcinoma]] who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. | ||
| + | *2019-11-06: New indication for the treatment of adult patients with metastatic [[Merkel cell carcinoma|Merkel cell carcinoma (MCC)]] | ||
| + | *2020-12-10: New indication for the maintenance treatment of patients with unresectable locally advanced or metastatic [[urothelial carcinoma|urothelial carcinoma (UC)]] whose disease has not progressed following first-line platinum-based chemotherapy. | ||
| + | |||
| + | ==History of changes in PMDA indication== | ||
| + | *2017-09-27: New approval for the treatment of unresectable [[Merkel cell carcinoma]]. | ||
| + | *2019-12-20: New indication and a new dosage for the treatment of unresectable or metastatic [[renal cell carcinoma]]. | ||
| + | *2021-02-24: New indication for the maintenance therapy of unresectable [[urothelial carcinoma]] in patients who have received chemotherapy. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' MSB-0010718C |
*'''Brand name:''' Bavencio | *'''Brand name:''' Bavencio | ||
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[[Category:Anti-PD-L1 antibodies]] | [[Category:Anti-PD-L1 antibodies]] | ||
| − | |||
[[Category:Merkel cell carcinoma medications]] | [[Category:Merkel cell carcinoma medications]] | ||
| − | [[Category: | + | [[Category:Clear cell renal cell carcinoma medications]] |
| + | [[Category:Urothelial carcinoma medications]] | ||
| + | |||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
| + | [[Category:EMA approved in 2017]] | ||
| + | [[Category:Health Canada approved in 2017]] | ||
| + | [[Category:PMDA approved in 2017]] | ||
Latest revision as of 00:57, 29 June 2024
General information
Class/mechanism: PD-L1 blocking antibody. PD-L1 (programmed death-1 ligand 1) expressed on tumor cells and tumor-infiltrating immune cells can result in inhibition of anti-tumor immune responses. Avelumab binds to PD-1 and B7.1 receptors on T-cells and antigen presenting cells and prevents PD-L1's inhibitory effects on the immune system. As a result, avelumab stimulates immune responses, including anti-tumor immune effects.[1][2][3]
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 or the prescribing information.[1]
Toxicity management
Diseases for which it is established
Patient drug information
- Avelumab (Bavencio) package insert[1]
- Avelumab (Bavencio) patient drug information (Chemocare)[4]
- Avelumab (Bavencio) patient drug information (UpToDate)[5]
History of changes in FDA indication
Merkel cell carcinoma
- 2017-03-23: Initial accelerated approval for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). (Based on JAVELIN Merkel 200)
Renal cell carcinoma
- 2019-05-14: Approved in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). (Based on JAVELIN Renal 101)
Urothelial carcinoma
- 2017-05-09: Granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. (Based on JAVELIN Solid Tumor)
- 2020-06-30: Full approval for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. (Converted to regular approval; expanded to maintenance setting; based on JAVELIN Bladder 100)
History of changes in EMA indication
- 2017-09-18: Initial marketing authorization as Bavencio. Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). (Based on JAVELIN Merkel 200)
- 2019-10-24: Extension of indication to include first-line combination treatment with avelumab and axitinib in adult patients with advanced renal cell carcinoma (aRCC).
- 2021-01-21: Extension of indication to include a new indication for Bavencio in the treatment as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum based chemotherapy.
History of changes in Health Canada indication
- 2017-12-18: Initial notice of compliance with conditions for the treatment of metastatic Merkel Cell Carcinoma (MCC) in previously treated adults.
- 2021-01-13: Conditions were met for the treatment of metastatic Merkel Cell Carcinoma (MCC) in previously treated adults.
- 2018-05-04: Notice of compliance with conditions for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy.
- 2019-05-14: Conditions were met for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy.
- 2019-11-06: New indication for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC)
- 2020-12-10: New indication for the maintenance treatment of patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed following first-line platinum-based chemotherapy.
History of changes in PMDA indication
- 2017-09-27: New approval for the treatment of unresectable Merkel cell carcinoma.
- 2019-12-20: New indication and a new dosage for the treatment of unresectable or metastatic renal cell carcinoma.
- 2021-02-24: New indication for the maintenance therapy of unresectable urothelial carcinoma in patients who have received chemotherapy.
Also known as
- Code name: MSB-0010718C
- Brand name: Bavencio