Difference between revisions of "Durvalumab (Imfinzi)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| + | ===[[Bladder cancer]] - '''WITHDRAWN'''=== | ||
| + | *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 [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]] ''(Initial approval)'' | ||
| + | **2/19/2021: Indication withdrawn after the confirmatory trial (DANUBE) did not meet its primary endpoints. | ||
| + | *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 within 12 months of neoadjuvant or adjuvant treatment with [[Regimen_classes#Platinum-based_regimen|platinum-containing chemotherapy]]. ''(Initial approval)'' | ||
| + | **2/19/2021: Indication withdrawn after the confirmatory trial (DANUBE) did not meet its primary endpoints. | ||
| + | |||
===[[Non-small cell lung cancer]]=== | ===[[Non-small cell lung cancer]]=== | ||
*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 [[Regimen_classes#Platinum-based_chemoradiation|concurrent platinum-based chemotherapy and radiation therapy]]. ''(New disease entity; based on PACIFIC)'' | *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 [[Regimen_classes#Platinum-based_chemoradiation|concurrent platinum-based chemotherapy and radiation therapy]]. ''(New disease entity; based on PACIFIC)'' | ||
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===[[Small cell lung cancer]]=== | ===[[Small cell lung cancer]]=== | ||
*3/27/2020: Approved in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage [[small cell lung cancer]] (ES-SCLC). ''(New disease entity; based on CASPIAN)'' | *3/27/2020: Approved in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage [[small cell lung cancer]] (ES-SCLC). ''(New disease entity; based on CASPIAN)'' | ||
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==Also known as== | ==Also known as== | ||
Revision as of 02:40, 10 December 2021
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
Diseases for which it was used
Patient drug information
History of changes in FDA indication
Bladder cancer - WITHDRAWN
- 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 (Initial approval)
- 2/19/2021: Indication withdrawn after the confirmatory trial (DANUBE) did not meet its primary endpoints.
- 5/1/2017: Granted FDA accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (Initial approval)
- 2/19/2021: Indication withdrawn after the confirmatory trial (DANUBE) did not meet its primary endpoints.
Non-small cell lung cancer
- 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. (New disease entity; based on PACIFIC)
Small cell lung cancer
- 3/27/2020: Approved in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). (New disease entity; based on CASPIAN)
Also known as
- Code name: MEDI4736
- Brand name: Imfinzi