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Immunotherapy medicines · checkpoint inhibitors

Tislelizumab (Tevimbra) in India: what it is and who it is for

Tislelizumab is a PD-1 immune checkpoint inhibitor given by drip. It is sold as Tevimbra, and it is available in India — the Central Drugs Standard Control Organisation approved it and Glenmark Pharmaceuticals launched it here in June 2025. Its Indian approval is narrower than its approvals abroad, and it is not suitable for most patients.

Prescription-only medicine. Tislelizumab (Tevimbra) is a prescription-only injectable medicine, given only in a hospital or day-care unit under a treating oncologist’s supervision, after the cancer type, stage and previous treatment have been assessed. Nothing on this page is a recommendation to use this medicine. It is not suitable for most patients — see "Who tislelizumab is not for" below.

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On this page

Regulatory status

Is tislelizumab approved and available in India?

Yes. The CDSCO approved tislelizumab, and Glenmark launched it in India as Tevimbra in June 2025. Its Indian approval covers non-small-cell lung cancer and oesophageal squamous cell carcinoma only, in defined lines of treatment. That is narrower than what the drug is approved for in Europe and China.

Check your cancer against the Indian label

Cancer on the biopsy report

On the Indian label, in defined lines of treatment

For non-small-cell lung cancer: first line, with chemotherapy, and second line, on its own. The highlighted rows below show what else has to be true.

Next: who it is not for

On the Indian label, in defined lines of treatment

For oesophageal squamous cell carcinoma: second line, on its own. The highlighted row below shows what else has to be true.

Next: who it is not for

Not on the Indian label for this cancer

Cancers outside its Indian approved list — the Indian label covers non-small-cell lung cancer and oesophageal squamous cell carcinoma. A diagnosis outside that list is not something a patient can request off-label because the drug costs less than the alternatives.

Not on the Indian label for this cancer

Oesophageal adenocarcinoma — the Indian approval names squamous cell carcinoma specifically. Histology on the biopsy report decides this, not the organ.

Not on the Indian label for this cancer

Gastric and gastro-oesophageal junction cancer — approved in some other countries, not part of the Indian label announced at launch. Retail listings that mention stomach cancer are describing a foreign label.

Ask a CION medical oncologist which medicine applies to your cancer. The consultation is free.

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SettingIndian approval as announced at launch (June 2025)What also has to be true
Non-small-cell lung cancer, first lineApproved in combination with chemotherapyLocally advanced or metastatic disease; the chemotherapy partner is chosen by the treating team
Non-small-cell lung cancer, second lineApproved as a single agentLocally advanced or metastatic disease that has progressed after earlier systemic treatment
Oesophageal squamous cell carcinoma, second lineApproved as a single agentSquamous histology specifically, and progression after earlier systemic treatment

In this table, first line means the first treatment given for the cancer, and second line means treatment given when that first treatment does not work or stops working. A single agent is one medicine used on its own. Histology is how the cells look under a microscope, as described on the biopsy report.

The regulatory trail is public. A Subject Expert Committee on oncology recommended import and marketing permission for tislelizumab injection in January 2025, and the launch followed in June 2025. New-drug approvals are listed by the CDSCO, which is the authority that decides what may be imported and marketed here.

Approved somewhere else is not approved here

This is the part worth reading twice, because online pharmacy pages get it wrong routinely. Search the brand name and you will find Indian retail listings describing it as a treatment for stomach cancer, liver cancer or Hodgkin lymphoma. Those descriptions are lifted from labels in other countries.

What each regulator has approved

The picture across regulators looks like this, from each authority’s own published information as at August 2026.

RegulatorPublicly reported approved usesWhat it means for an Indian prescription
CDSCO (India)First-line NSCLC with chemotherapy; second-line NSCLC alone; second-line oesophageal squamous cell carcinoma aloneThis is the label that governs here
US FDAOesophageal squamous cell carcinoma, and first-line gastric or gastro-oesophageal junction adenocarcinoma with chemotherapyNot an Indian approval; the gastric setting is not on the Indian label
EMA (European Union)Indications listed for non-small-cell lung cancer, small cell lung cancer, oesophageal and gastric or gastro-oesophageal junction cancersNot an Indian approval; the small cell and gastric settings are not on the Indian label
China NMPAA wider list, including settings such as classical Hodgkin lymphoma, liver, urothelial and nasopharyngeal cancersNot an Indian approval; these are the indications most often copied into Indian retail listings

Compiled from the Indian launch announcement, the EMA public assessment report for Tevimbra and the US prescribing information published on DailyMed, checked August 2026.

Approved indications change. If a pharmacy page says this medicine treats your cancer, that is not the same as your oncologist saying it, and it is not the same as the Indian label saying it.

Who tislelizumab 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 discovered at the pharmacy counter. Tislelizumab is generally not used, or is used only with specialist caution, in these situations:

The first test is your cancer type: see the label check above.

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.

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What it is

What is tislelizumab?

Tislelizumab is a PD-1 immune checkpoint inhibitor. It is a humanised IgG4 monoclonal antibody given as an intravenous infusion, sold under the brand name Tevimbra. It blocks the PD-1 brake on T cells, which is intended to let the immune system recognise certain cancers. It is a hospital medicine, not a tablet.

Most people arrive at this name because it is written on a prescription, not because they were looking for a drug class. So the plain version first: tislelizumab belongs to the same family as pembrolizumab and nivolumab. All three target PD-1. They are different molecules, made by different companies, approved for different cancers, and priced very differently in India.

Tislelizumab at a glance

It was developed by BeiGene, which now operates as BeOne Medicines. Its design difference, as described by the developer, is that the antibody is engineered to minimise binding to Fc-gamma receptors on macrophages. In India it is marketed by Glenmark Pharmaceuticals under a marketing and distribution agreement with BeiGene, and its Indian launch in June 2025 was Glenmark’s first entry into immuno-oncology.

DetailTislelizumab at a glance
MoleculeTislelizumab, a humanised IgG4 anti-PD-1 monoclonal antibody
Brand name in IndiaTevimbra
ClassPD-1 immune checkpoint inhibitor — the same class as pembrolizumab and nivolumab
How it is givenIntravenous infusion in a day-care unit; not oral, not self-administered
Presentation100 mg in 10 mL, single-dose vial
StorageCold chain, 2–8 °C, in the original carton; do not freeze, do not shake
DeveloperBeiGene, now BeOne Medicines
Marketer in IndiaGlenmark Pharmaceuticals, under agreement with the developer

Summarised from the company’s Indian launch announcement of June 2025 and from published Indian product listings, checked August 2026. It is an orientation, not the approved product label.

Cost context

How much does tislelizumab cost, and how does it compare?

Published Indian retail listings for the 100 mg vial ran from roughly ₹45,000 to ₹61,000 when checked in August 2026. A standard 200 mg dose is two vials. On those listings, the drug alone works out at roughly ₹0.9 lakh to ₹1.2 lakh for one three-weekly cycle, before any hospital charges.

That number matters most for the family who has already been told what pembrolizumab costs and has quietly decided immunotherapy is out of reach. Newer PD-1 entrants have started to move Indian pricing in this class, and tislelizumab is one of the clearest examples so far. It does not make the class cheap. It does change the arithmetic enough to be worth checking rather than assuming.

MedicineVial commonly listedPublished Indian listing (indicative, as of August 2026)
Tislelizumab (Tevimbra)100 mg / 10 mLMRP listed near ₹61,000, with discounted retail listings around ₹45,000–₹57,000
Pembrolizumab (Keytruda)100 mgMRP around ₹2.08 lakh, with selling prices commonly reported between ₹1.5 lakh and ₹1.9 lakh
Nivolumab, originator (Opdyta)40 mg and 100 mgRoughly ₹36,000 to over ₹90,000 per vial depending on the dosage form
Nivolumab, Indian biosimilar40 mg and 100 mg₹13,950 and ₹28,950 as announced at its January 2026 Indian launch

Read down that column and the shape of the change is obvious. At the listings quoted, a three-weekly tislelizumab dose costs somewhere between about a quarter and two-fifths of a three-weekly pembrolizumab dose. Nivolumab moved further and for a different reason: its Indian patent lapsed in May 2026, and a domestic biosimilar launched in January 2026 at roughly a quarter of the reference price. Pembrolizumab’s patent protection is expected to begin lapsing around 2028–29.

Three cautions before that table is used to argue for a switch.

  1. Price is not the deciding variable.

    These medicines are not interchangeable. The approved indication, the line of treatment, the histology and any biomarker result decide which one applies. A cheaper PD-1 drug that is not approved for your cancer is not an option at any price.

  2. The vial price is a fraction of the bill.

    Day care, nursing, pre-cycle blood tests, response-assessment scans and any chemotherapy given alongside are billed separately. Response-assessment imaging is generally coordinated at partner imaging centres rather than performed in-house.

  3. Listings move, and they differ from each other.

    Retail pharmacy MRPs, discounted online listings, hospital pharmacy rates and any manufacturer support arrangement can all differ on the same day.

The figures above are third-party published listings and announcements, quoted so the arithmetic is visible. They are indicative, as of August 2026. They are not a hospital rate for this molecule, and no rate for it is quoted on this page. Ask for a written, itemised estimate before the first cycle, and ask separately what your insurer or scheme will and will not cover — high-cost immunotherapy is frequently capped or excluded.

Tislelizumab is not the only newer PD-1 medicine changing what this class costs in India. If the question behind your search is really “is there a cheaper drug that would work for my cancer?”, read Toripalimab, Sintilimab and Other Newer PD-1 Medicines next — it covers the other entrants and, more importantly, which of them are actually approved here.

Administration and dose

How is tislelizumab given, and how is the dose worked out?

Tislelizumab is given as an intravenous infusion in a day-care unit. The commonest adult schedule is a flat 200 mg every three weeks, which is two 100 mg vials. The first infusion runs over about 60 minutes; later ones may be given over about 30 minutes if the first was tolerated.

What happens at each visit

  1. Before the cycleblood tests check thyroid, liver, kidney and blood-count values, and you are asked about any new symptom since the last visit. A cycle delayed because of a blood result is routine, not a setback.
  2. Reviewthe oncologist confirms the dose and that it is safe to proceed that day.
  3. The infusiona cannula is placed and the drug runs in, over about an hour the first time.
  4. Short observationa monitoring period for infusion reactions before you go home. Most people go home the same day.
  5. Between cyclesyou 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.
A flat dose, and the other schedules

The dose is a flat dose, not a dose per kilogram of body weight. That surprises people who have been through chemotherapy, where body surface area and weight drive almost everything. The product information also describes 150 mg every two weeks, 300 mg every four weeks and 400 mg every six weeks as alternative schedules; which one is used depends on the indication and on the treating team’s plan. Why some immunotherapy drugs are dosed flat and others by weight is set out in how immunotherapy doses are calculated: mg/kg vs flat dose.

There is no home version. Some checkpoint inhibitors now exist in an under-the-skin form that shortens the visit, and that difference is explained in subcutaneous injection vs IV drip versions of immunotherapy. Tislelizumab in India is an intravenous product.

Vials are cold-chain products stored between 2 and 8 °C in the original carton. They are not frozen, not shaken, and not transported casually. If a vial is being sourced from outside the treating hospital’s own pharmacy, the cold chain and the source both need checking before it is used.

Safety

What side effects can tislelizumab 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.

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.

Reported common effects include fatigue, muscle or joint pain, cough, reduced appetite and weight loss, along with blood-test changes such as anaemia, a fall in lymphocyte count, low sodium, low albumin, raised blood sugar and raised liver enzymes. Many of these show on a blood report before the person feels anything, which is exactly why the pre-cycle tests are done.

Immune-related events are defined as much by when they appear as by what they are. Skin rash and thyroid changes tend to show earliest. Colitis, hepatitis and pneumonitis often appear later in a course, and some events surface weeks or months after the final dose.

Live vaccines are generally avoided during treatment, and steroids taken for an unrelated reason should be declared, because they interact with how this class is managed. 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.

What the evidence covers

What is the evidence behind tislelizumab?

The approvals rest on the RATIONALE programme of phase 3 trials, run across lung and oesophageal cancers. Each approved setting has its own trial. Benefit is described in that programme in a proportion of patients, in the specific population studied, and not everyone in those trials responded.

That last clause is not a hedge. It is how this class works. A checkpoint inhibitor aims to remove a brake on the immune system so that it can act against the tumour; in some people it does, in some it does not, and no scan or blood test available today predicts the outcome for an individual with certainty. Anyone who tells you otherwise about any drug in this class is overselling it.

Long-term data on this molecule is still accumulating, as it is across the checkpoint-inhibitor class. Late immune-related effects, effects on fertility, and second-cancer risk after immunotherapy are areas where the evidence is genuinely immature, and any page that speaks confidently about them is going beyond what is known.

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What the treating team can tell you is narrower and more useful: which indication you fall under, what the response assessment schedule will be, and what will happen if the first scan shows no benefit. Ask for those three answers before the first cycle, not after the third.

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Is your situation different?

Common questions

Tislelizumab (Tevimbra): frequently asked questions

How long will I need to stay on tislelizumab?

Tislelizumab's product information sets no fixed end date. Treatment can continue until the cancer gets worse or side effects become too severe, and whether to continue is usually reviewed at each scan. Some oncologists plan a fixed course instead, often around two years. CION's page on how long immunotherapy continues explains who decides when to stop.

Can tislelizumab cause a reaction while the drip is running?

It can, though most people do not have one. Signs include fever, chills, flushing, itching, a rash or breathlessness. Tell the nurse at once, even if it feels minor. A mild reaction is usually handled by slowing or pausing the drip. A severe one can mean tislelizumab is stopped for good.

Can I buy tislelizumab from an outside pharmacy and bring it in?

A licensed pharmacy may legally sell it against your oncologist's prescription. But the day-care unit giving the drip decides whether to use a vial you bring. Many units decline vials whose storage they cannot check. Ask the unit before paying, because a bought vial usually cannot be returned. CION's page on why cold chain matters lists the questions to ask a pharmacy first.

How can I check that a tislelizumab vial is genuine?

You cannot tell just by looking. Check that the carton seal is unbroken. The batch number and expiry should match on the vial, carton and invoice. Tislelizumab is imported, so its label should show an import licence number and the importer's name. The QR-code rule for cancer medicines starts in July 2027, so until then a missing QR code alone does not mean a fake. CION's guide to checking a vial explains what to do if unsure.

Is tislelizumab the same as pembrolizumab or nivolumab?

No, but all three are PD-1 checkpoint inhibitors and they work on the same brake in the immune system. They are different molecules from different manufacturers, with different approved indications, different dosing schedules and very different prices in India. They are not interchangeable, and one cannot simply be swapped for another because it costs less. Which one applies is decided by your cancer type, its stage, the line of treatment and any biomarker result, not by preference. Newer PD-1 entrants such as tislelizumab have started to change what this class costs in India, but they have not widened who is eligible for it.

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Sources for this page
  1. CDSCO — Recommendations of the SEC (Oncology), meeting of 16 January 2025 (tislelizumab injection) · Jan 2025
  2. CDSCO — Approved new drugs · checked Aug 2026
  3. BioSpectrum India — Glenmark introduces oncology drug Tevimbra in India · Jun 2025
  4. European Medicines Agency — Tevimbra: EPAR · checked Aug 2026
  5. European Medicines Agency — Tevimbra: product information (SmPC) · Sep 2026
  6. US National Library of Medicine, DailyMed — Tevimbra prescribing information · checked Aug 2026
  7. BeOne Medicines — China NMPA approves tislelizumab for previously treated urothelial carcinoma · retrieved Sep 2026
  8. NCI Dictionary of Cancer Terms — non-small cell lung cancer · retrieved Sep 2026
  9. NCI Dictionary of Cancer Terms — first-line therapy · retrieved Sep 2026
  10. NCI Dictionary of Cancer Terms — second-line therapy · retrieved Sep 2026
  11. NCI Dictionary of Cancer Terms — monotherapy (single agent) · retrieved Sep 2026
  12. NCI Dictionary of Cancer Terms — histology · retrieved Sep 2026

New answers on this page also draw on CION's own published pages on infusion reactions, buying and storing immunotherapy medicines, checking a vial is genuine, reading an immunotherapy prescription and how long immunotherapy continues.

Medical disclaimer: General information about a prescription medicine, not a prescription or a treatment plan. Do not start, stop or change any treatment because of this page, and contact your own treating team about anything that worries you.

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