Difference between revisions of "Avelumab (Bavencio)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Bladder cancer]]=== | ===[[Bladder cancer]]=== | ||
| − | * | + | *2017-05-09: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm557162.htm Granted accelerated approval] for patients with locally advanced or metastatic [[bladder cancer|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: Approved for maintenance treatment of patients with locally advanced or metastatic [[bladder cancer|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)'' |
===[[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)'' |
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *2017-12-18: Initial notice of compliance with conditions | ||
| + | *2018-05-04: Notice of compliance with conditions for the treatment of patients with locally advanced or metastatic [[Bladder cancer|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. | ||
| + | *2021-01-13: Conditions were met | ||
==Also known as== | ==Also known as== | ||
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[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
[[Category:EMA approved in 2017]] | [[Category:EMA approved in 2017]] | ||
| + | [[Category:Health Canada approved in 2017]] | ||
Revision as of 15:20, 29 March 2023
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Toxicity management
Diseases for which it is established (work in progress)
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
Bladder cancer
- 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: Approved 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)
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)
History of changes in Health Canada indication
- 2017-12-18: Initial notice of compliance with conditions
- 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.
- 2021-01-13: Conditions were met
Also known as
- Code name: MSB0010718C
- Brand name: Bavencio