Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC)…. Sold as Imfinzi. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Durvalumab (sold as Imfinzi), first approved May 1, 2017, with 16 new uses approved and 0 published complete response letters.
First approved: May 1, 2017
Applications: 1
New uses approved: 16
Complete response letters: 0
Medicare spending, 2025: $1.18B
Orphan exclusivity until: Nov 25, 2032
First approved in the EU: Sep 21, 2018
First approved in Japan: Jul 2, 2018
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 14 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
ImfinziDrugs with a new indication and a new dosage for the preoperative and postoperative adjuvant treatment for non-small cell lung cancer and preoperative and… · AstraZeneca K.K. · Sep 19, 2025
ImfinziDrugs with a new indication and a new dosage for maintenance treatment of limited-stage small cell lung cancer following definitive chemoradiation therapy. · AstraZeneca K.K. · Mar 27, 2025
ImfinziDrugs with a new indication and a new dosage for the treatment of advanced or recurrent endometrial cancer. · AstraZeneca K.K. · Nov 22, 2024
ImfinziDrugs with a new dosage indicated for the maintenance treatment of locally-advanced, unresectable non-small cell lung cancer following definitive… · AstraZeneca K.K. · Nov 24, 2023
ImfinziDrugs with a new indication and a new dosage for the treatment of unresectable biliary tract cancer. · AstraZeneca K.K. · Dec 23, 2022
Imfinzi(1) Drugs with a new indication and a new dosage for the treatment of unresectable advanced or recurrent non-small-cell lung cancer. · AstraZeneca K.K. · Dec 23, 2022
ImfinziDrugs with a new indication and a new dosage for the treatment of extensive-stage small-cell lung cancer. · AstraZeneca K.K. · Aug 21, 2020 · Review report
Imfinzi, new ingredientDrugs with a new active ingredient indicated for the maintenance treatment of locally-advanced, unresectable non-small cell lung cancer following definitive… · AstraZeneca K.K. · Jul 2, 2018 · Review report
Clinical Trials
424 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
