Difference between revisions of "Durvalumab (Imfinzi)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *5/1/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555930.htm Granted FDA accelerated approval] | + | *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 [[ | + | **Have disease progression during or following [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]] |
| − | **Have disease progression within 12 months of neoadjuvant or adjuvant treatment with [[ | + | **Have disease progression within 12 months of neoadjuvant or adjuvant treatment with [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]]. |
| − | *2/16/2018: FDA approved | + | *2/16/2018: FDA approved for patients with unresectable stage III [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] whose disease has not progressed following concurrent [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]] and radiation therapy. |
==Also known as== | ==Also known as== | ||
Revision as of 06:05, 10 January 2020
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 CD80 (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. [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 is used
Patient drug information
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.
- 2/16/2018: FDA approved for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
Also known as
- Code name: MEDI4736
- Brand name: Imfinzi