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.

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.

Detail Tislelizumab at a glance
Molecule Tislelizumab, a humanised IgG4 anti-PD-1 monoclonal antibody
Brand name in India Tevimbra
Class PD-1 immune checkpoint inhibitor — the same class as pembrolizumab and nivolumab
How it is given Intravenous infusion in a day-care unit; not oral, not self-administered
Presentation 100 mg in 10 mL, single-dose vial
Storage Cold chain, 2–8 °C, in the original carton; do not freeze, do not shake
Developer BeiGene, now BeOne Medicines
Marketer in India Glenmark 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.

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 the United States, Europe and China.

The regulatory trail is public. A Subject Expert Committee on oncology recommended import and marketing permission for tislelizumab injection in February 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.

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

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.

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

Regulator Publicly reported approved uses What it means for an Indian prescription
CDSCO (India) First-line NSCLC with chemotherapy; second-line NSCLC alone; second-line oesophageal squamous cell carcinoma alone This is the label that governs here
US FDA Oesophageal squamous cell carcinoma, and first-line gastric or gastro-oesophageal junction adenocarcinoma with chemotherapy Not 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 cancers Not an Indian approval; the small cell and gastric settings are not on the Indian label
China NMPA A wider list, including settings such as classical Hodgkin lymphoma, liver, urothelial and nasopharyngeal cancers Not 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.

Cost Context

How does the cost of tislelizumab 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.

Medicine Vial commonly listed Published Indian listing (indicative, as of August 2026)
Tislelizumab (Tevimbra) 100 mg / 10 mL MRP listed near ₹61,000, with discounted retail listings around ₹45,000–₹57,000
Pembrolizumab (Keytruda) 100 mg MRP around ₹2.08 lakh, with selling prices commonly reported between ₹1.5 lakh and ₹1.9 lakh
Nivolumab, originator (Opdyta) 40 mg and 100 mg Roughly ₹36,000 to over ₹90,000 per vial depending on the dosage form
Nivolumab, Indian biosimilar 40 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.

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:

  • 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.
  • Oesophageal adenocarcinoma — the Indian approval names squamous cell carcinoma specifically. Histology on the biopsy report decides this, not the organ.
  • 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.
  • 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 — pneumonitis is one of the serious immune-related risks of this class, and pre-existing lung disease changes that calculation.
  • Pregnancy and breastfeeding — it is not recommended in pregnancy, and breastfeeding is advised against during treatment and for a period after the last dose.
  • Poor overall performance status, and significant liver disease — 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 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.

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.

  1. Before the cycle — blood 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. 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, over about an hour the first time.
  4. Short observation — a monitoring period for infusion reactions before you go home. Most people go home the same day.
  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.

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.

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.

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.

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.

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.

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.

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.

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.

Common questions

Tislelizumab (Tevimbra): Frequently Asked Questions

Is tislelizumab available in India?

Yes. Tislelizumab was approved by the Central Drugs Standard Control Organisation and launched in India in June 2025 under the brand name Tevimbra, marketed here by Glenmark Pharmaceuticals under an agreement with the developer, BeiGene, now BeOne Medicines. It is supplied as a 100 mg per 10 mL single-dose vial that has to be kept refrigerated between 2 and 8 degrees Celsius. Availability is not the same as suitability. It is a prescription-only hospital medicine, and its Indian approval covers a narrow list of cancers.

Which cancers is tislelizumab approved for in India?

The Indian approval announced at launch covers two cancers only. The first is locally advanced or metastatic non-small-cell lung cancer, where tislelizumab is approved in combination with chemotherapy as first-line treatment and as a single agent in the second line. The second is oesophageal squamous cell carcinoma, where it is approved as a single agent in the second line. Approvals in the United States, the European Union and China are wider and include settings such as gastric cancer that are not part of the Indian label. The label that applies to your diagnosis in India is the one that governs.

How much does tislelizumab cost in India?

Published Indian retail listings for the 100 mg vial ranged from about 45,000 to about 61,000 rupees when checked in August 2026, depending on the pharmacy and the discount applied. A standard adult dose of 200 mg is made up from two vials, so the drug alone works out at roughly 90,000 to 1.2 lakh rupees for one three-weekly cycle. These figures are indicative, as of August 2026, and are third-party published prices rather than a hospital rate. Day care, nursing, pre-cycle blood tests, scans and any chemotherapy given alongside are billed separately.

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.

How is tislelizumab given, and how often?

Tislelizumab is given as a drip into a vein in a day-care unit, not as a tablet and not at home. The commonest adult schedule is a flat 200 mg every three weeks, which is two 100 mg vials. The product information also describes 150 mg every two weeks, 300 mg every four weeks and 400 mg every six weeks, and the treating team chooses the schedule. The first infusion runs over about 60 minutes, and later infusions may be given over about 30 minutes if the first one was tolerated. The dose is a flat dose, not calculated per kilogram of body weight.

Who should not receive tislelizumab?

Most people with cancer are not candidates. It is not used for cancers outside its Indian approved list, and within oesophageal cancer the Indian approval names squamous cell carcinoma specifically, not adenocarcinoma. Caution or exclusion applies to people with active autoimmune disease needing systemic immunosuppression, solid-organ transplant recipients on anti-rejection medicines, people already taking high-dose steroids for another condition, and people with significant existing lung inflammation or interstitial lung disease. It is not recommended in pregnancy or while breastfeeding. Only your own oncology team can decide eligibility from your reports, scans and treatment history.