Approved Indications

Which cancers is durvalumab (Imfinzi) approved for in India?

Durvalumab is not approved for cancer in general. It is approved in India for a defined list of settings, each cleared separately by the Central Drugs Standard Control Organisation. Within each one, only certain stages, prior treatments or biomarker results qualify.

The list has widened in steps rather than all at once. Durvalumab first entered Indian practice on the strength of the PACIFIC evidence in unresectable stage 3 non-small-cell lung cancer, and AstraZeneca Pharma India has since announced a series of CDSCO permissions to import and market the 120 mg/2.4 mL and 500 mg/10 mL vials for additional indications. Each addition is separate. A cancer type that is not on the list is not an off-label choice a patient can request.

Cancer type Publicly reported Indian status (Aug 2026) What usually also has to be true
Unresectable stage 3 non-small-cell lung cancer The original and still the dominant Indian use, on the PACIFIC evidence Disease has not progressed after concurrent platinum-based chemoradiation
Extensive-stage small cell lung cancer Approved with etoposide and a platinum drug in the first-line setting Extensive-stage disease as defined in the label
Limited-stage small cell lung cancer CDSCO permission reported by the company in 2025 Disease has not progressed after platinum-based chemoradiation
Biliary tract cancer Approved in combination with gemcitabine and cisplatin Locally advanced or metastatic disease per the label
Hepatocellular carcinoma (liver) CDSCO permission reported in 2025, in combination with tremelimumab Unresectable disease per the label
Muscle-invasive bladder cancer CDSCO permission reported July 2025 Neoadjuvant with gemcitabine and cisplatin, then adjuvant after radical cystectomy
Advanced or recurrent endometrial cancer CDSCO permission reported February 2026 First line with carboplatin and paclitaxel, then maintenance; mismatch-repair status decides the maintenance arm

Indicative summary of publicly reported regulatory announcements and news coverage, checked August 2026. It is a starting point for the conversation with your oncologist — not the approved product label, and not a suitability check. The label that applies to your exact diagnosis governs, and it changes over time.

Stage 3 Lung Cancer

Why is durvalumab given after chemoradiation, and not instead of it?

Because that is where the evidence sits. In unresectable stage 3 non-small-cell lung cancer, chemotherapy and radiation given together is the curative-intent treatment. Durvalumab follows it as consolidation, aimed at disease the chemoradiation may have left behind. It does not replace either.

Consolidation is the word that confuses people most on this prescription. It means a course given after the main treatment has finished, in someone who has responded, to lower the chance of the cancer coming back. It is not a rescue treatment and it is not started because chemoradiation failed. If the restaging scan shows the disease has progressed, consolidation durvalumab is not the next step — the plan changes instead.

This sequence was established by the PACIFIC trial, and NCCN lists consolidation durvalumab as its Category 1 option after concurrent chemoradiation in this setting. It aims to reduce the chance of recurrence in a proportion of patients. It does not do so in everyone, and the trade-off is an added layer of immune-related risk on top of a chest that has just been irradiated.

  1. Staging and multidisciplinary review — imaging and biopsy confirm stage 3 disease, and the team decides whether the tumour can be removed surgically. Durvalumab consolidation belongs to the unresectable path.
  2. Concurrent chemoradiation — platinum-based chemotherapy and radiotherapy given together, usually over about six weeks. Why both are given at the same time is explained in concurrent chemoradiation: why both together.
  3. Restaging scan and recovery review — the team confirms the disease has not progressed and that acute radiation effects, especially in the lungs, have settled enough to proceed.
  4. Consolidation durvalumab begins — started as soon after chemoradiation as the label and the patient’s recovery allow, because delay is thought to matter in this setting.
  5. Up to 12 months, or until it stops — treatment runs for a defined maximum in this indication, and stops earlier for progression, a serious immune-related event, or the patient’s decision.

If the prescription says durvalumab but no radiation has been given, the setting is a different one — small cell lung cancer, biliary tract, liver, bladder or endometrial disease each have their own approved combination and schedule. Ask which indication yours is; it changes the dose, the partner drugs and the duration.

Cost Context

What does durvalumab (Imfinzi) cost in India?

Durvalumab comes in two vial strengths, 120 mg/2.4 mL and 500 mg/10 mL. Published Indian retail listings for the 500 mg vial sat at roughly ₹1.7–1.9 lakh when checked in August 2026. What you actually pay is set by dose, cycle count and the charges around each infusion.

Three things make a single vial price a poor guide to the total. Dosing is either 10 mg/kg every two weeks or a fixed 1,500 mg every four weeks for adults at or above 30 kg, so one four-weekly dose is usually made up from three 500 mg vials. Cycle count varies by indication — the stage 3 lung consolidation course runs up to 12 months. And the drug is only part of the bill: day care, nursing, pre-cycle blood tests and response-assessment imaging are charged separately.

Cost element What it depends on Published reference point (indicative, as of August 2026)
Drug — 500 mg/10 mL vial Number of vials per dose Listed on the Indian retail pharmacy site 1mg at an MRP of about ₹1.90 lakh with a discounted listing near ₹1.71 lakh; other Indian distributor listings reported in the ₹1.3–1.5 lakh range
Drug — 120 mg/2.4 mL vial Used to make up weight-based doses Priced proportionally lower; confirm the current figure at the dispensing hospital pharmacy
Dose schedule Indication and body weight 10 mg/kg every 2 weeks, or a fixed 1,500 mg every 4 weeks at 30 kg and above — a 1,500 mg dose is three 500 mg vials
Number of cycles Indication, response and tolerance Stage 3 lung consolidation runs up to 12 months — about 13 four-weekly cycles if completed
Day care, nursing, pre-cycle blood tests Each visit Billed by the treating centre, separately from the drug
Response-assessment imaging Scan interval set by the oncologist Usually coordinated at an imaging centre and billed separately from treatment

Those are third-party published listings, checked in August 2026, quoted so the arithmetic is visible. They are not a hospital rate for this molecule, and no rate for it is quoted on this page. Retail pharmacy listings, hospital pharmacy rates and any manufacturer patient-support arrangement can differ from each other, and all of them move. Ask for a written, itemised estimate before the first cycle, and ask separately what the state scheme, CGHS, ECHS or your insurer will and will not cover — high-cost immunotherapy is frequently capped or excluded, and finding that out at cycle four is far worse than finding it out now.

Who durvalumab is not for

Most people who search this drug name are not candidates for it. That is the most useful sentence on this page, and it is better read now than assumed away. Durvalumab is generally not used, or is used only with specialist caution, in these situations:

  • Cancers outside its approved list — if your diagnosis is not one of the approved indications, it is not an option that can be requested.
  • Stage 3 lung cancer that can be operated on — consolidation durvalumab belongs to the unresectable path. A resectable tumour follows a different plan.
  • Disease that has already progressed after chemoradiation — consolidation is for disease that has not progressed. Progression means the plan changes, not that this drug is added.
  • Active autoimmune disease needing systemic immunosuppression — releasing an immune brake can worsen it.
  • Solid-organ transplant recipients on anti-rejection medicines — there is a real risk of graft rejection.
  • People already on high-dose steroids for another condition — this needs individual assessment before any decision is made.
  • Significant existing lung inflammation or interstitial lung disease — particularly relevant here, because the chest has usually just been irradiated. Specialist judgement is required.
  • Pregnancy, and poor overall performance status — both are weighed carefully against any expected benefit.

It is also not an immunity booster, not a preventive, and not something to add to a plan without telling the treating team. Eligibility can only be decided by your own oncology team from your own reports, scans and treatment history.

Administration And Monitoring

How is durvalumab given, and for how long?

Durvalumab is given as an intravenous infusion in a day-care oncology unit, typically over about an hour. Most people go home the same day. In the stage 3 lung consolidation setting the schedule is commonly a fixed 1,500 mg every four weeks, up to a maximum of 12 months.

It is not a tablet and it cannot be taken at home. Nothing about the infusion itself requires admission, sedation or hair loss — this drug does not cause the hair loss chemotherapy is associated with.

  1. Before the cycle — blood tests check thyroid, liver, kidney and blood-count values, and you are asked about new symptoms since the last visit. A delayed cycle because of a blood result is routine, not a setback.
  2. Review — the oncologist confirms the dose and that it is safe to proceed that day.
  3. The infusion — a cannula is placed and the drug runs in, usually over about 60 minutes.
  4. Short observation — a period of monitoring for infusion reactions before you leave.
  5. Between cycles — you watch for new symptoms and report them promptly. Immune-related effects can appear weeks or months after a dose, and even after treatment has finished.

Duration depends on the indication. Stage 3 lung consolidation has a defined 12-month ceiling. In advanced-disease settings such as extensive-stage small cell, biliary tract or liver cancer, treatment usually continues while it appears to be working and is tolerated, reviewed at each scan. In every setting it stops earlier for progression, for a serious immune-related event, or because the patient chooses to stop — which is a legitimate choice, not a failure.

Safety

What side effects can durvalumab cause?

The characteristic risks are immune-related adverse events — the immune system inflaming a healthy organ. The commonest involve the thyroid, skin, gut, liver and lungs. Most are manageable when caught early. Inflammation of the lungs, bowel, heart muscle or adrenal glands is a medical emergency.

Lung inflammation deserves particular attention in the stage 3 lung setting. Radiation to the chest can itself cause pneumonitis, and drug-related pneumonitis can look identical. New breathlessness or a persistent dry cough after chemoradiation is never something to wait out at home on the assumption that it is "just the radiation" — it needs assessment, and the distinction matters because the treatments differ.

Immune-related events are defined as much by when they appear as by what they are. Skin rash and thyroid changes tend to show up earliest. Colitis, hepatitis and pneumonitis often appear later in a course, and some events surface weeks or months after the final dose. That is why pre-cycle blood tests continue throughout, and why any new symptom is worth mentioning even when it seems unrelated.

Symptoms that need urgent assessment, not home management: new or worsening breathlessness, or a persistent dry cough; loose motions that increase in number or contain blood; chest pain or palpitations; severe unexplained fatigue with dizziness, vomiting or collapse; yellowing of the eyes or skin. For any of these, contact your treating oncology team immediately or go to the nearest emergency department. Do not self-medicate and do not wait for the next scheduled cycle. Tell any doctor who sees you, in any department, that you are on immunotherapy — it changes how these symptoms are investigated.

Symptom-by-symptom guidance sits on the dedicated side-effect pages rather than here. This page is an orientation to the medicine, not a triage tool.

Common questions

Durvalumab (Imfinzi): Frequently Asked Questions

Which cancers is durvalumab (Imfinzi) approved for in India?

Durvalumab is not approved for cancer in general. It is approved in India for a defined list of settings, each cleared separately by the CDSCO. Publicly reported approvals cover unresectable stage 3 non-small-cell lung cancer after chemoradiation, extensive-stage and limited-stage small cell lung cancer, biliary tract cancer, unresectable hepatocellular carcinoma with tremelimumab, muscle-invasive bladder cancer, and advanced or recurrent endometrial cancer. Within each of those, only certain stages, prior treatments or biomarker results qualify. The approved label that applies to your exact diagnosis governs, and that list changes over time.

Why is durvalumab given after chemoradiation in stage 3 lung cancer?

In unresectable stage 3 non-small-cell lung cancer, concurrent chemotherapy and radiation is given with curative intent, but the cancer comes back in a large share of patients. Durvalumab is added afterwards as consolidation, meaning it is not the main treatment but a course that follows it, aimed at disease the chemoradiation may have left behind. This sequence was established by the PACIFIC trial and is listed by NCCN as its Category 1 consolidation option in that setting. It is used only when the disease has not progressed on the restaging scan.

What does durvalumab (Imfinzi) cost in India?

Durvalumab is supplied in India in two vial strengths, 120 mg per 2.4 mL and 500 mg per 10 mL. Published Indian retail listings for the 500 mg vial were around 1.7 to 1.9 lakh rupees when checked in August 2026, with some distributor listings lower. These figures are indicative, as of August 2026, and are published third-party prices, not a rate from any hospital. The total depends on the dose, since a fixed 1500 mg dose is made up from three 500 mg vials, on how many cycles are given, and on day-care, blood-test and imaging charges billed separately.

How long does durvalumab treatment continue?

It depends on the indication. In the stage 3 lung cancer consolidation setting the label specifies a maximum of 12 months, which is about 13 four-weekly cycles if it is given to completion. In advanced-disease settings it is usually continued while it appears to be working and is tolerated, reviewed at each scan. Treatment stops earlier if the cancer progresses, if a serious immune-related side effect develops, or if the person decides to stop. That decision belongs to the treating oncologist and the patient together, scan by scan.

Who should not receive durvalumab?

Most people with cancer are not candidates. It is not used for cancers outside its approved list, and in stage 3 lung cancer it is not used if the tumour is operable or if the disease has already progressed after chemoradiation. Extra caution or exclusion applies to people with active autoimmune disease needing systemic immunosuppression, solid-organ transplant recipients on anti-rejection medicines, people already on high-dose steroids for another reason, and people with significant existing lung inflammation. Pregnancy and poor performance status are weighed carefully. Only your own oncology team can decide this from your reports.

What is the difference between durvalumab and pembrolizumab?

Both are checkpoint inhibitors, but they block different points on the same pathway. Durvalumab binds PD-L1 on tumour cells. Pembrolizumab binds PD-1 on T cells. In practice the more useful difference is where each one is approved. Durvalumab is the drug most often used as consolidation after chemoradiation in unresectable stage 3 lung cancer, while pembrolizumab is used across a wider list of advanced cancers and often depends on a PD-L1 score. They are not interchangeable, and which one applies is set by your cancer type, stage and biomarker results, not by preference or price.