Durvalumab
A PD-L1 blocker that became standard after chemoradiation for stage III lung cancer, and now in bladder, biliary, and gastric cancers.
Overview
PACIFIC (unresectable stage III NSCLC), ADRIATIC (limited-stage SCLC, 2024), TOPAZ-1 (biliary tract), HIMALAYA (HCC with tremelimumab), NIAGARA (perioperative muscle-invasive bladder cancer, 2025), MATTERHORN (perioperative gastric, 2025), and Q2 2026 high-risk non-muscle-invasive bladder cancer with BCG (POTOMAC). Partner of Dato-DXd in TROPION-Breast05.
Human IgG1 anti-PD-L1 with reduced Fc effector function.
1.Antibody binds PD-L1
- Route
- IV infusion
- Schedule
- 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks (≥30 kg); up to 12 months after chemoradiation in stage III NSCLC
- Dose modifications
- Hold for grade 2 pneumonitis; discontinue for grade 3-4
- Monitoring
- Respiratory symptoms after chemoradiation, thyroid, LFTs, creatinine
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- VENTANA PD-L1 (SP263) Assay · TC at least 1% (durvalumab after chemoradiotherapy, NSCLC; PACIFIC-derived)
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9173.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- AstraZeneca Access 360
- AZ&Me Prescription Savings
- PAN Foundation: Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Unresectable stage III NSCLC after chemoradiation (PACIFIC)
- Notes
- Moved to routine commissioning after the CDF period. Also extensive-stage SCLC with platinum-etoposide (TA798), and with tremelimumab in HCC (TA916). Perioperative treatment with FLOT then adjuvant durvalumab alone for resectable gastric or gastro-oesophageal junction adenocarcinoma: TA1160 (June 2026). Untreated advanced or recurrent mismatch repair deficient endometrial cancer with platinum chemotherapy then maintenance durvalumab: TA1190 (September 2026), with a 3-year stop; the maintenance combination with olaparib for mismatch repair proficient disease was not recommended in the same guidance. Limited-stage small cell lung cancer that has not progressed after platinum chemoradiotherapy (ADRIATIC): TA1099 (October 2025), within the licence.
- Cancer Drugs Fund
- Entered the Indication Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA578 · NHS England Indication Drugs Fund list · SMC advice: durvalumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
- 1 May 2017ApprovalUS
Urothelial carcinoma (accelerated; later withdrawn 2021) source
- 16 Feb 2018ApprovalUS
Unresectable stage III NSCLC after chemoradiation (PACIFIC) source
- 27 Mar 2020ApprovalUS
Extensive-stage SCLC with chemotherapy (CASPIAN) source
- 2 Sept 2022ApprovalUS
Biliary tract cancer with chemotherapy (TOPAZ-1) source
- 21 Oct 2022ApprovalUS
HCC with tremelimumab (HIMALAYA) source
- 4 Dec 2024ApprovalUS
Limited-stage SCLC after chemoradiation (ADRIATIC) source
- 28 Mar 2025ApprovalUS
Perioperative muscle-invasive bladder cancer (NIAGARA) source
- Nov 2025ApprovalUS
Perioperative gastric/GEJ cancer with FLOT (MATTERHORN) source
- 28 May 2026ApprovalUS
High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Locally advanced or metastatic urothelial carcinoma after platinum (accelerated; indication withdrawn 2021) |
| US | 2018 | Unresectable stage III NSCLC after chemoradiation |
| US | 2026 | High-risk NMIBC with BCG |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Pneumonitis (any cause, PACIFIC) vs 12.8% placebo; 1.1% fatal | 18.3% | - |
| Cough PACIFIC; all-grade ≥20% | - | - |
| Fatigue PACIFIC; all-grade ≥20% | - | - |
| Radiation pneumonitis PACIFIC; all-grade ≥20% | - | - |
| Upper respiratory infection PACIFIC; all-grade ≥20% | - | - |
| Dyspnoea PACIFIC; all-grade ≥20% | - | - |
| Rash PACIFIC; all-grade ≥20% | - | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | astrazeneca-us.com/medicines/access-360 |
| United Kingdom | NICE: recommended after chemoradiation in stage III NSCLC (TA798), biliary tract cancer, limited-stage SCLC, perioperative bladder and gastric cancer | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topTrials recruiting now
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Landmark trials
Latest papers
topQuery for this drug: (TITLE:"Durvalumab" OR ABSTRACT:"Durvalumab" OR TITLE:"Imfinzi" OR ABSTRACT:"Imfinzi") AND (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Durvalumab, not a curated reading list.
Similar pages
not linked directly; found by shared links- CompanyBoston Scientific
Shares TheraSphere With Durvalumab and Tremelimumab for HCC, Radioembolisation (TARE) with durvalumab in hepatocellular carcinoma, Hepatocellular carcinoma.
- IsotopeHolmium-166
Shares Intermediate hepatocellular carcinoma (BCLC B), Hepatocellular carcinoma.
- CompanySirtex Medical
Shares Radioembolisation (TARE) with durvalumab in hepatocellular carcinoma, Hepatocellular carcinoma.
- PairingRadioembolisation (TARE) compared with sorafenib in hepatocellular carcinoma
Shares Intermediate hepatocellular carcinoma (BCLC B), Hepatocellular carcinoma.
- CompanyQuirem Medical
Shares Intermediate hepatocellular carcinoma (BCLC B), Hepatocellular carcinoma.
- IsotopeYttrium-90
Shares A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepat, TheraSphere With Durvalumab and Tremelimumab for HCC, Intermediate hepatocellular carcinoma (BCLC B), Radioembolisation (TARE) with durvalumab in hepatocellular carcinoma.
- TechnologyRadioembolisation (TARE / SIRT, yttrium-90)
Shares Intermediate hepatocellular carcinoma (BCLC B), Radioembolisation (TARE) with durvalumab in hepatocellular carcinoma, Hepatocellular carcinoma.
- CompanyMerck & Co. (MSD)