Durvalumab
A PD-L1 blocker that became standard after chemoradiation for stage III lung cancer, and now in bladder, biliary, and gastric cancers.
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.
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.
- 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).
- Cancer Drugs Fund
- Entered the Cancer 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 Cancer Drugs Fund list · SMC advice: durvalumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 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
- Q2 2026ApprovalUS
High-risk non-muscle-invasive bladder cancer with BCG (POTOMAC) source
Approvals
| Region | Year | Indication |
|---|---|---|
| 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
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Patients with limited-stage small-cell lung cancer who complete chemoradiotherapy without progression should now be offered up to two years of durvalumab consolidation, which extends life by almost two years on average. This is the first survival improvement for limited-stage disease since twice-daily radiotherapy and prophylactic cranial irradiation, and small-cell lung cancer is no longer a disease where immunotherapy gives only marginal gains.
Patients fit enough for cisplatin whose bladder cancer has invaded the muscle wall should now be offered durvalumab with their pre-operative chemotherapy and for about a year after surgery, which improves the chance of cure without compromising the operation. The trial cannot say whether the adjuvant phase is necessary, or how to treat cisplatin-ineligible patients, for whom other trials are ongoing.
Patients with stage III lung cancer that cannot be removed surgically should receive a year of durvalumab after completing chemoradiotherapy, provided they have not progressed. This roughly doubles the chance of being alive without progression at five years. Whether the benefit extends to PD-L1-negative tumours is contested, and the EGFR-mutated subgroup is better served by osimertinib (LAURA).
Latest papers
topQuery for this drug: (TITLE:"Durvalumab" OR ABSTRACT:"Durvalumab" OR TITLE:"Imfinzi" OR ABSTRACT:"Imfinzi") AND (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.
Pages like this
not linked directly; found by shared links- ProductAtezolizumab
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