Difference between revisions of "Durvalumab (Imfinzi)"
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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. Durvalumab 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, durvalumab stimulates immune responses, including anti-tumor immune effects. Durvalumab is being investigated for potential use as monotherapy or in combination with [[tremelimumab (ticilimumab)]] in [[non-small cell lung cancer]], [[head and neck cancer]], [[bladder cancer]], [[gastric cancer]], [[pancreatic cancer]], [[Hepatobiliary cancer|hepatocellular carcinoma]], and blood cancers.<ref>[https://www.astrazeneca.com/media-centre/press-releases/2016/Durvalumab-granted-Breakthrough-Therapy-designation-by-US-FDA-for-treatment-of-patients-with-PD-L1-positive-urothelial-bladder-cancer-17022016.html Durvalumab granted Breakthrough Therapy designation by US FDA for treatment of patients with PD-L1 positive urothelial bladder cancer] (AstraZeneca)</ref> | 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. Durvalumab 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, durvalumab stimulates immune responses, including anti-tumor immune effects. Durvalumab is being investigated for potential use as monotherapy or in combination with [[tremelimumab (ticilimumab)]] in [[non-small cell lung cancer]], [[head and neck cancer]], [[bladder cancer]], [[gastric cancer]], [[pancreatic cancer]], [[Hepatobiliary cancer|hepatocellular carcinoma]], and blood cancers.<ref>[https://www.astrazeneca.com/media-centre/press-releases/2016/Durvalumab-granted-Breakthrough-Therapy-designation-by-US-FDA-for-treatment-of-patients-with-PD-L1-positive-urothelial-bladder-cancer-17022016.html Durvalumab granted Breakthrough Therapy designation by US FDA for treatment of patients with PD-L1 positive urothelial bladder cancer] (AstraZeneca)</ref> | ||
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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. | 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. | ||
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| + | ==Diseases for which it is used== | ||
| + | *[[Bladder_cancer]] | ||
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| + | ==History of changes in FDA indication== | ||
| + | *5/1/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555930.htm Granted FDA accelerated approval] "for the treatment of patients with locally advanced or metastatic [[bladder cancer|urothelial carcinoma]] who: | ||
| + | **Have disease progression during or following [[:Category:Platinum_agents|platinum-containing]] chemotherapy | ||
| + | **Have disease progression within 12 months of neoadjuvant or adjuvant treatment with [[:Category:Platinum_agents|platinum-containing]] chemotherapy." | ||
| + | |||
| + | ==Also known as== | ||
| + | MEDI4736 | ||
==References== | ==References== | ||
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[[Category:Antibody medications]] | [[Category:Antibody medications]] | ||
[[Category:Anti-PD-L1 antibodies]] | [[Category:Anti-PD-L1 antibodies]] | ||
| − | [[Category: | + | [[Category:Bladder cancer medications]] |
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| + | [[Category:FDA approved in 2017l]] | ||
Revision as of 19:52, 1 May 2017
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. Durvalumab 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, durvalumab stimulates immune responses, including anti-tumor immune effects. Durvalumab is being investigated for potential use as monotherapy or in combination with tremelimumab (ticilimumab) in non-small cell lung cancer, head and neck cancer, bladder cancer, gastric cancer, pancreatic cancer, hepatocellular carcinoma, and blood cancers.[1]
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.
Diseases for which it is used
History of changes in FDA indication
- 5/1/2017: Granted FDA accelerated approval "for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- Have disease progression during or following platinum-containing chemotherapy
- Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy."
Also known as
MEDI4736