Durvalumab (Imfinzi)
An anti-PD-L1 immune checkpoint inhibitor used in lung, biliary tract, liver, bladder, and other cancers, alone or with chemotherapy or tremelimumab.
What is Durvalumab?
What it targets
The PD-L1 protein on cancer and immune cells. Blocking PD-L1 stops it from switching off T cells, releasing the immune brake so the immune system can attack the tumour.
Who it may help
Patients with specific cancers and stages where durvalumab is approved, who have adequate organ function and no major autoimmune or immunosuppression barrier to immunotherapy.
Why testing matters
Testing confirms the cancer type, stage, and biomarkers. dMMR status is needed for endometrial cancer, and EGFR/ALK must be excluded in some lung cancer settings where targeted therapy is preferred.
Which cancers can Durvalumab treat?
Durvalumab is approved across several cancers. The exact indication and access vary by country and hospital.
| Stage III NSCLC (unresectable) | Single-agent consolidation after platinum-based chemoradiation when disease has not progressed (PACIFIC). A global standard of care in this curative-intent setting. |
| Resectable NSCLC (perioperative) | With chemotherapy before surgery and as durvalumab after surgery for resectable NSCLC without EGFR or ALK changes (AEGEAN). Approved by FDA in 2024. |
| Extensive-stage SCLC | First-line with etoposide plus carboplatin or cisplatin, then durvalumab maintenance (CASPIAN). |
| Limited-stage SCLC | Single-agent consolidation after concurrent chemoradiation when disease has not progressed (ADRIATIC). FDA approved December 2024; CDSCO India approved March 2025. |
| Biliary tract cancer | With gemcitabine and cisplatin for locally advanced or metastatic biliary tract cancer including cholangiocarcinoma and gallbladder cancer (TOPAZ-1). |
| Hepatocellular carcinoma (HCC) | With a single priming dose of tremelimumab (the STRIDE regimen) for unresectable HCC in eligible patients (HIMALAYA). |
| Bladder cancer | Perioperative with gemcitabine and cisplatin for muscle-invasive bladder cancer (NIAGARA, 2025), and with BCG for high-risk non-muscle-invasive bladder cancer (POTOMAC, 2026). |
| Gastric and endometrial cancer | With FLOT chemotherapy for resectable gastric or GEJ cancer (MATTERHORN, 2025), and with chemotherapy for dMMR advanced or recurrent endometrial cancer (DUO-E). |
Are you eligible for Durvalumab?
Eligibility depends on the confirmed cancer type, stage, biomarker status, organ function, and immune history.
- Confirmed diagnosis and stage matching an approved durvalumab indication
- For consolidation settings, disease that has not progressed after chemoradiation
- For lung cancer in some settings, EGFR and ALK changes excluded, as those patients usually need targeted therapy first
- For endometrial cancer, mismatch repair (dMMR) status confirmed by testing
- Adequate liver, kidney, lung, and blood function on baseline tests
- No active severe autoimmune disease that could flare dangerously on immunotherapy
- Not on high-dose steroids or strong immunosuppression that would blunt the immune effect
- Pregnancy excluded, with effective contraception in place where relevant
How does Durvalumab work?
- Cancer hides from the immune system
- Durvalumab blocks the stop signal
- T cells are reactivated
- The immune system attacks the cancer
Durvalumab does not attack cancer directly. It takes the brakes off your own immune system so it can do the work.
Tests required before starting Durvalumab
These tests confirm the diagnosis, guide eligibility, and establish baselines to monitor for immune-related side effects.
| Biopsy and histopathology | Confirms the exact cancer type and is the basis for all treatment decisions |
| Imaging and staging | CT, PET-CT, MRI, or bone scan as needed to define stage and create a baseline to measure response |
| Biomarker and molecular testing | dMMR/MMR for endometrial cancer; EGFR, ALK, ROS1 and NGS for lung cancer where targeted therapy may be preferred; PD-L1 if relevant locally |
| Blood counts and organ function | CBC, liver and kidney function tests, and electrolytes to confirm fitness and set baselines |
| Thyroid and endocrine baseline | Thyroid function and blood sugar, since immunotherapy can affect hormone glands |
| Infection and immune screen | Hepatitis B and C, HIV, and review of autoimmune disease, transplant history, and steroid or immunosuppressant use |
| Liver assessment for HCC | Child-Pugh score, viral hepatitis status, and varices or bleeding risk evaluation when relevant before HCC treatment |
How is Durvalumab given?
Durvalumab is given as an intravenous infusion in a day care or hospital infusion centre. The dose and schedule depend on the cancer type and combination.
| Stage III NSCLC and limited-stage SCLC | Single agent, commonly 1500 mg every 4 weeks (or 10 mg/kg every 2 weeks), for a fixed period such as up to about a year |
| With chemotherapy (BTC, ES-SCLC, gastric) | Usually 1500 mg with chemotherapy every 3 weeks for several cycles, followed by durvalumab maintenance every 4 weeks |
| HCC (STRIDE regimen) | A single priming dose of tremelimumab 300 mg plus durvalumab 1500 mg, then durvalumab 1500 mg every 4 weeks |
| Lower body weight | Patients under 30 kg are dosed by weight, for example 20 mg/kg, as set out in the prescribing information |
| Each infusion | Given over about an hour, with monitoring during and after for infusion reactions |
| Missed or delayed dose | Infusions are scheduled by the cancer centre; if you miss an appointment, contact them to rebook as soon as possible |
| Duration | Fixed-period in consolidation and perioperative settings; in advanced disease, often until progression or unacceptable side effects |
Clinical evidence and benefits
Durvalumab has improved outcomes across several cancers in large phase 3 trials. Benefit varies by tumour type, stage, and patient fitness.
| Stage III NSCLC (PACIFIC) | Consolidation durvalumab after chemoradiation substantially improved long-term disease control and survival, establishing it as a standard of care |
| Limited-stage SCLC (ADRIATIC) | Durvalumab after chemoradiation significantly improved overall and progression-free survival versus placebo, the first immunotherapy benefit in this setting |
| Biliary tract cancer (TOPAZ-1) | Adding durvalumab to gemcitabine and cisplatin improved survival in advanced biliary tract cancer compared with chemotherapy alone |
| Hepatocellular carcinoma (HIMALAYA) | The STRIDE regimen with tremelimumab roughly doubled five-year survival versus sorafenib in unresectable HCC, with durable responses in a subset |
| Muscle-invasive bladder cancer (NIAGARA) | Perioperative durvalumab with chemotherapy significantly reduced the risk of recurrence and death versus chemotherapy alone |
| Resectable gastric/GEJ cancer (MATTERHORN) | Perioperative durvalumab with FLOT chemotherapy improved event-free survival versus chemotherapy alone in resectable disease |
Individual responses vary. These reflect published phase 3 trial results and do not guarantee outcomes for any single patient.
Side effects of Durvalumab
Durvalumab is generally better tolerated than chemotherapy, but it can cause immune-related side effects, where the activated immune system inflames healthy organs. Some appear during treatment and some weeks to months after.
| Fatigue | Very common; usually mild to moderate and manageable with rest and pacing |
| Cough or breathlessness | May be minor, but new or worsening breathing symptoms can signal lung inflammation (pneumonitis) and must be reported |
| Diarrhoea or colitis | Loose stools are common; frequent or bloody diarrhoea can mean bowel inflammation and needs urgent review |
| Rash and itching | Common skin reactions; usually managed with creams or antihistamines, rarely severe |
| Thyroid changes | Underactive or overactive thyroid is frequent; treated with hormone tablets and monitored with blood tests |
| Liver inflammation (hepatitis) | Raised liver enzymes are monitored on blood tests; severe cases may need steroids and a treatment pause |
| Nausea or reduced appetite | More common when combined with chemotherapy; managed with anti-nausea medicines |
| Hormone gland problems | Adrenal, pituitary, or pancreas inflammation can occur, sometimes causing low cortisol or new diabetes; needs prompt treatment |
| Infusion reactions | Fever, chills, or flushing during or shortly after the infusion; the rate may be slowed or treated |
| Kidney inflammation | Less common; detected through blood tests and changes in urine output |
Contact your doctor immediately if you develop:
- New or worsening cough, chest pain, or difficulty breathing
- Severe or persistent diarrhoea, blood in stool, or severe abdominal pain
- Yellowing of the eyes or skin, dark urine, or severe nausea
- Severe headache, confusion, dizziness, fainting, or vision changes
- Extreme fatigue, rapid heartbeat, or unexplained weight changes (possible hormone problem)
- High fever, severe rash, blistering, or signs of an allergic reaction
Safety precautions and what to tell your team
Tell your oncologist your full medical history and every medicine, supplement, and herbal product you take before starting durvalumab.
- Tell the team about any autoimmune disease such as lupus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, or myasthenia gravis, which can flare on immunotherapy
- Report any prior organ transplant or stem cell transplant, as immunotherapy can trigger rejection or graft complications
- Mention lung disease, prior pneumonitis, pulmonary fibrosis, or heavy chest radiation, which raise the risk of lung inflammation
- Share any liver disease, hepatitis B or C, or abnormal liver tests before starting
- High-dose steroids or strong immunosuppressant medicines may reduce how well durvalumab works and should be reviewed
- Live vaccines are generally avoided during treatment; check timing of any vaccines with your team
- Durvalumab can harm a developing baby; effective contraception is needed where relevant and breastfeeding is usually not advised
- Report any active or recent serious infection before each cycle
Durvalumab combination treatments
Durvalumab is used alone in some settings and combined with other treatments in others, chosen by the oncologist based on cancer type and approvals.
| With chemoradiation (consolidation) | Given after concurrent chemotherapy and radiation in stage III NSCLC and limited-stage SCLC once disease has not progressed |
| With chemotherapy | Combined with platinum-etoposide in ES-SCLC, gemcitabine and cisplatin in biliary tract cancer, FLOT in gastric cancer, and carboplatin-paclitaxel in dMMR endometrial cancer |
| With tremelimumab | A single priming dose of the CTLA-4 inhibitor tremelimumab is added for unresectable HCC (STRIDE) and for some metastatic NSCLC regimens |
| With surgery (perioperative) | Given before and after surgery with chemotherapy in resectable NSCLC, muscle-invasive bladder cancer, and gastric cancer |
| With BCG (bladder) | Combined with BCG therapy for high-risk non-muscle-invasive bladder cancer in eligible patients |
If Durvalumab stops working
Some cancers do not respond to immunotherapy from the start, and others respond and then progress later. Understanding which is happening guides the next step.
| Primary resistance | The cancer never responds, often because the tumour environment is not recognised by the immune system. Chemotherapy or targeted therapy may be used instead |
| Acquired resistance | The cancer responds and then progresses after a period of control; a repeat biopsy or molecular test can help find new options |
| Confirming progression | Imaging is repeated to confirm true growth, since immunotherapy can occasionally cause pseudoprogression where scans worsen before improving |
| Next-line options | Depending on the cancer, options include chemotherapy, targeted therapy if a mutation is found, radiation, locoregional treatment, or a clinical trial |
Cost of Durvalumab by country
Durvalumab is a biologic with no generic, so it is expensive. Total cost also depends on dose, body weight in some regimens, combination medicines, scans, and side-effect management.
| India | Marketed by AstraZeneca as Imfinzi in 120 mg and 500 mg vials; cost runs into lakhs per course. Hospital pricing and patient assistance may reduce the burden |
| China | Available through approved channels for indications such as biliary tract cancer and lung cancer; cost and any reimbursement vary by city and hospital |
| USA | List price is high per cycle; most patients rely on insurance, and AstraZeneca runs patient assistance and co-pay support programmes |
| UK / Europe | Funded through the NHS and national health systems for approved indications, with little or no out-of-pocket cost for eligible patients |
| UAE / Gulf | Available at major oncology centres; coverage depends on the insurance plan and indication, often needing prior authorisation |
Availability of Durvalumab globally
Durvalumab is available in many oncology markets as branded Imfinzi. The approved indication and practical access differ by country.
India
Marketed by AstraZeneca Pharma India as Imfinzi. CDSCO approvals include stage III NSCLC, limited-stage SCLC (2025), and biliary tract cancer. Access for other indications should be checked against the current Indian label.
China
Approved by the NMPA for selected indications including extensive-stage SCLC, stage III NSCLC, and first-line biliary tract cancer with chemotherapy. Access for HCC and other uses should be confirmed by the hospital.
USA
FDA approved across lung, biliary tract, liver, bladder, gastric, and dMMR endometrial cancers. Widely available through specialty pharmacy with patient assistance programmes.
UK
Available on the NHS for approved indications such as stage III NSCLC and SCLC, subject to NICE and national funding decisions.
Germany / EU
Approved by the EMA and funded by national insurance systems across the EU for its approved indications, including monotherapy uses in HCC in some countries.
Durvalumab in current clinical trials
Durvalumab is studied widely across cancers, often in earlier-stage and combination settings.
| Earlier-stage and perioperative use | Trials are extending durvalumab into curative-intent, before-and-after-surgery settings across lung, bladder, gastric, and other cancers |
| New combinations | Studies combine durvalumab with chemotherapy, radiation, targeted therapy, antibody-drug conjugates, and other immune agents |
| Biomarker selection | Research aims to identify which patients benefit most, refining the role of PD-L1, dMMR, and other markers |
| Resistant and pretreated disease | Trials explore options for patients whose cancer progresses on or after immunotherapy |
Your treatment journey with Durvalumab
Diagnosis and staging
Biomarker and safety assessment
Treatment planning
Starting infusions
Monitoring for immune side effects
Response assessment
Continuation or next steps
Questions to ask your oncologist about Durvalumab
- Is Durvalumab approved for my cancer type and stage in my country?
- Do I need PD-L1, dMMR, or EGFR/ALK testing before starting?
- Will Durvalumab be used alone or with other treatments?
- What is the schedule and how long will treatment last?
- Which side effects should I report immediately?
- How will my lungs, liver, thyroid, and kidneys be monitored?
- What happens if I develop pneumonitis, colitis, or a hormone problem?
- What is the expected cost and are there assistance options?
How CancerFax supports Durvalumab patients
CancerFax helps patients understand where durvalumab fits, navigate access, and connect with the right specialists across India, China, and other countries.
| Report review | Upload your biopsy, scans, and biomarker reports such as dMMR, EGFR, or ALK, and our team will review them and explain what they mean for durvalumab eligibility |
| Specialist connection | We connect patients with medical and radiation oncologists experienced in immunotherapy for lung, liver, biliary tract, bladder, and other cancers |
| Second opinion | If you are unsure whether immunotherapy is right, or your cancer has progressed, we arrange an expert second opinion to review options |
| International access coordination | For patients considering treatment in India or China, CancerFax helps with hospital options, indication access, travel, and translation |
| Cost and access navigation | We help patients understand pricing, check whether assistance programmes apply, and identify practical access routes for this expensive biologic |
Frequently asked questions about Durvalumab
Common questions from patients and caregivers
Durvalumab is an immunotherapy, not a chemotherapy. It does not kill cells directly. Instead it blocks a protein called PD-L1 that some cancers use to switch off the immune system, which can help your own T cells recognise and attack the cancer. Because it works through the immune system, its side effects are different from chemotherapy and are mostly inflammation-related rather than hair loss or severe nausea.
Yes, PD-L1 testing is often required to determine if atezolizumab is right for you. Your tumour tissue is tested using an approved assay to measure PD-L1 expression level, which guides dosing and combination decisions. Ask your oncologist which test was done on your biopsy and what your result means for your treatment options.
Immunotherapy can take longer than chemotherapy to show an effect. The first response scan is usually done after a few cycles, often around 8 to 12 weeks. Some patients have a slow but durable response, and a small number have what is called pseudoprogression, where scans look worse before they improve. Your oncologist interprets your scans alongside your symptoms.
The two most important safety warnings for sacituzumab govitecan are severe neutropenia (dangerously low white blood cells) and severe diarrhea, both of which can be life-threatening if untreated. You should contact your oncology team immediately if you develop fever, chills, severe diarrhea, signs of infection, or difficulty breathing. Regular blood count monitoring is required throughout treatment to catch neutropenia early.
Treatment duration depends on the setting. In consolidation settings such as stage III NSCLC or limited-stage SCLC, durvalumab is usually given for a fixed period, commonly up to about a year or two. In advanced or metastatic disease, it often continues until the cancer progresses or side effects become a problem. Never stop or pause without your oncologist, as the plan is tailored to your situation.
If the cancer grows during or after durvalumab, your oncologist confirms progression on imaging and may repeat a biopsy or molecular testing. Next steps depend on the cancer type and can include chemotherapy, targeted therapy if a mutation is found, radiation, locoregional treatment, or a clinical trial. A second opinion can help identify newer options and trial access in India, China, and other countries.
Yes. Sorafenib is available as generic versions in several countries, including India, where it has an important history linked to the country's first compulsory licence for a cancer drug. Generic sorafenib contains the same active ingredient at the same dose and has been used widely. Ask your oncologist or pharmacist about generic availability and legitimate sourcing in your country. CancerFax can also help with access guidance across India, China, and other regions.
Durvalumab is not recommended during pregnancy because immune checkpoint inhibitors can harm the developing baby. Women who can become pregnant should use effective contraception during treatment and for a period after the last dose, as advised in local prescribing information. Breastfeeding is usually not advised during and for some time after treatment. Discuss family planning with your oncology team before starting.