Nivolumab (Opdivo) for Lung Cancer, Melanoma & Other Cancers: India Supply
Nivolumab (Opdivo) for Lung Cancer, Melanoma and Other Advanced Cancers: A Plain-English Guide
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last updated: September 2026
Few cancer drugs carry as many separate approvals as the one this article covers. It is a PD-1 inhibitor — a type of immunotherapy — approved across eleven different cancer types, from lung cancer to mesothelioma, sometimes alone and sometimes paired with another immunotherapy, chemotherapy, or a targeted drug.
Because the approved combinations and dosing vary so much by cancer type, this guide focuses on how the treatment works in general, which cancers it covers, what the FDA-reviewed trial data actually showed for each one, and what to expect around side effects and access. Every figure below is drawn directly from the current FDA-approved prescribing information, not from journal articles or secondhand summaries. Approvals and label wording change over time and differ by country, so this is background reading — not a replacement for what your own oncologist tells you.
At a Glance
| Drug class | PD-1 (programmed death receptor-1) blocking antibody — a checkpoint inhibitor immunotherapy, not chemotherapy |
| Brand name | Opdivo (nivolumab), Bristol Myers Squibb |
| How it is given | Intravenous (IV) infusion, alone or combined with another immunotherapy, chemotherapy, or a targeted drug, depending on the cancer |
| Cancers covered | Eleven types — see the table below |
| Typical dose | 240 mg every 2 weeks, 360 mg every 3 weeks, or 480 mg every 4 weeks as a fixed dose — the exact regimen and combination partner depend on the specific cancer and treatment line |
| Before starting | Not every use needs a biomarker test, but several do (for example, PD-L1 or MSI-H/dMMR testing) — ask which applies to your case |
| Main safety concern | Immune-mediated side effects — the immune system can be switched on against healthy organs, not just the tumor |
| Good to know | Not a cure in most settings; it is used to extend the time a cancer stays controlled, and in a few settings, to reduce the risk of recurrence after surgery |
How Does It Work?
T-cells are the immune system's cancer-fighting cells. Many tumors protect themselves by activating a checkpoint protein called PD-1 on T-cells, which effectively switches those T-cells off before they can attack.
PD-1 A checkpoint receptor on T-cells that, once triggered, tells the immune system to stand down. | PD-L1 A protein many tumors display to trigger that PD-1 checkpoint and hide from the immune system. | What this drug does Blocks PD-1 so the checkpoint cannot be triggered. T-cells stay active and can recognize and attack the tumor. |
This is why it is called a checkpoint inhibitor: it does not attack cancer cells directly the way chemotherapy does. It releases a brake the immune system already had, which is also why the main safety risk is an immune system that becomes overactive against normal tissue, not the classic chemotherapy side effects like hair loss.
Why Is It Sometimes Combined With Another Immunotherapy?
- A related drug, ipilimumab, blocks a different checkpoint (CTLA-4). Combining the two switches on the immune response through two separate mechanisms at once.
- Combinations generally produce a stronger response than either drug alone, but also a higher rate of immune-related side effects — which is why the combination is reserved for specific cancers and risk groups on the label, not used everywhere.
The Trade-Off in One Line
More checkpoints blocked at once generally means a stronger response and a higher chance of an immune-related side effect — which is why the FDA has approved this combination for some cancers and risk groups, and not others.
PD-L1 Testing
- Several approvals require the tumor to express PD-L1 above a certain threshold, measured on a biopsy sample using an FDA-authorized test.
- Some cancers are treated regardless of PD-L1 status; others specifically require a positive result. This varies by cancer type and is noted in the table below.
Which Cancers Is This Approved For?
The table gives the current FDA-approved picture. Several cancers have more than one approved use (for example, both a first-line combination and a later-line single-agent option) — the sections after the table go into more detail for each.
| Cancer | Typical setting | Usually combined with |
|---|---|---|
| Non-small cell lung cancer (NSCLC) | Resectable disease before/after surgery, or metastatic disease, first-line or after chemotherapy | Chemotherapy, ipilimumab, or given alone |
| Melanoma | Unresectable/metastatic disease, or after surgery to reduce recurrence risk | Alone or with ipilimumab |
| Renal cell carcinoma (RCC) | First-line advanced disease, or after prior anti-angiogenic therapy | Ipilimumab, cabozantinib, or given alone |
| Classical Hodgkin lymphoma | Previously untreated Stage III/IV, or relapsed after stem cell transplant | AVD chemotherapy, or given alone |
| Head and neck squamous cell carcinoma | Recurrent or metastatic, after platinum-based therapy | Given alone |
| Urothelial carcinoma | After surgery (high recurrence risk), first-line metastatic, or after chemotherapy | Cisplatin and gemcitabine, or given alone |
| Colorectal cancer (MSI-H/dMMR) | Unresectable or metastatic, any treatment line | Ipilimumab, or given alone |
| Hepatocellular carcinoma (HCC) | Unresectable or metastatic, first-line or after sorafenib | Ipilimumab |
| Esophageal cancer | After surgery with residual disease, or advanced squamous cell disease | Chemotherapy, ipilimumab, or given alone |
| Gastric, gastroesophageal junction and esophageal adenocarcinoma | Advanced or metastatic, PD-L1 expressing | Chemotherapy |
| Malignant pleural mesothelioma | Unresectable, first-line | Ipilimumab |
Non-Small Cell Lung Cancer
This is the largest of the eleven approvals, covering everything from early, operable disease to advanced disease that has already progressed on chemotherapy.
- Before and after surgery (neoadjuvant/adjuvant), combined with chemotherapy, for resectable tumors.
- First-line metastatic disease, combined with ipilimumab (for PD-L1≥1% tumors) or with ipilimumab plus two cycles of chemotherapy (regardless of PD-L1 status).
- As a single agent, after disease progression on platinum-based chemotherapy.
| 17.1 vs 14.9 months | CheckMate-227 · NCT02477826 Median overall survival, first-line combined with ipilimumab vs chemotherapy, in patients with PD-L1≥1% tumors (hazard ratio 0.79). |
| 12.2 vs 9.4 months | CheckMate-057 · NCT01673867 Median overall survival, single agent vs chemotherapy, in previously treated non-squamous NSCLC (hazard ratio 0.73). |
Melanoma
Melanoma is where this class of drug first transformed outcomes for advanced disease, and it remains one of its best-studied uses.
- As a single agent or combined with ipilimumab, for unresectable or metastatic melanoma.
- As adjuvant treatment after complete surgical removal of Stage IIB through Stage IV disease, to lower the chance of recurrence.
| NR vs 36.9 vs 19.9 mo | CheckMate-067 · NCT01844505 Median overall survival with combination therapy (not reached), single-agent therapy (36.9 months), and ipilimumab alone (19.9 months), based on extended follow-up (hazard ratio 0.55 for combination vs ipilimumab alone). The trial was not designed to prove the combination beats single-agent treatment directly. |
Renal Cell Carcinoma
- First-line, combined with ipilimumab, for intermediate- or poor-risk advanced disease.
- First-line, combined with the targeted drug cabozantinib, regardless of risk category.
- As a single agent, after prior anti-angiogenic therapy (such as a VEGF-targeted drug).
| NR vs 25.9 months | CheckMate-214 · NCT02231749 Median overall survival, combined with ipilimumab vs sunitinib, in intermediate/poor-risk patients (hazard ratio 0.63). |
| 37.7 vs 34.3 months | CheckMate-9ER · NCT03141177 Updated median overall survival, combined with cabozantinib vs sunitinib (hazard ratio 0.70). |
Classical Hodgkin Lymphoma
- Combined with AVD chemotherapy, for previously untreated Stage III or IV disease.
- As a single agent, for disease that has relapsed after autologous stem cell transplant and brentuximab vedotin, or after three or more prior lines of therapy including transplant.
| HR 0.42 | SWOG S1826 · NCT03907488 Progression-free survival, combined with AVD vs brentuximab vedotin plus AVD, in previously untreated Stage III/IV disease. Events occurred in 5.6% vs 12.4% of patients over the follow-up period studied. |
| 66–69% response rate | Pooled relapsed/refractory data Confirmed overall response rate as a single agent in patients who had relapsed after stem cell transplant, across two supporting trials (CheckMate-205 and CheckMate-039). |
Head and Neck Squamous Cell Carcinoma
Approved as a single agent for disease that has come back or spread after platinum-based chemotherapy.
| 7.5 vs 5.1 months | CheckMate-141 · NCT02105636 Median overall survival vs investigator-selected of chemotherapy (cetuximab, methotrexate or docetaxel), hazard ratio 0.70. |
Urothelial Carcinoma
- As adjuvant treatment after surgery, in patients at high risk of the cancer returning.
- First-line metastatic disease, combined with cisplatin and gemcitabine.
- As a single agent, after disease progression on platinum-based chemotherapy.
| 21.7 vs 18.9 months | CheckMate-901 · NCT03036098 Median overall survival, first-line combined with cisplatin and gemcitabine vs chemotherapy alone (hazard ratio 0.78). |
| 20.8 vs 10.8 months | CheckMate-274 · NCT02632409 Median disease-free survival as adjuvant treatment after surgery, vs placebo (hazard ratio 0.70). |
Colorectal Cancer (MSI-H or dMMR)
This approval applies only to a specific biomarker subset — tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), meaning they have lost the ability to correctly repair certain DNA errors. This is a minority of colorectal cancers overall, but one where checkpoint inhibitors work unusually well.
| NR vs 5.8 months | CheckMate-8HW · NCT03143153 Median progression-free survival, first-line combined with ipilimumab vs chemotherapy, in centrally confirmed MSI-H/dMMR disease (hazard ratio 0.21). |
Hepatocellular Carcinoma
- First-line, combined with ipilimumab, for unresectable or metastatic disease.
- Combined with ipilimumab, for disease previously treated with sorafenib.
| 23.7 vs 20.6 months | CheckMate-9DW · NCT04039607 Median overall survival, first-line combined with ipilimumab vs investigator-selected of lenvatinib or sorafenib (hazard ratio 0.79). |
Esophageal Cancer
- As adjuvant treatment after complete surgical resection, in patients with residual disease following chemoradiotherapy.
- First-line advanced or metastatic squamous cell carcinoma, combined with chemotherapy or with ipilimumab, in PD-L1-expressing tumors.
- As a single agent, after prior fluoropyrimidine- and platinum-based chemotherapy.
| 22.4 vs 11.0 months | CheckMate-577 · NCT02743494 Median disease-free survival as adjuvant treatment vs placebo (hazard ratio 0.69). |
| 15.4 vs 9.1 months | CheckMate-648 Median overall survival, first-line combined with chemotherapy vs chemotherapy alone, in PD-L1-expressing squamous cell carcinoma (hazard ratio 0.54). |
Gastric, Gastroesophageal Junction and Esophageal Adenocarcinoma
Approved for advanced or metastatic disease that expresses PD-L1, combined with chemotherapy, as first-line treatment.
| 14.4 vs 11.1 months | CheckMate-649 · NCT02872116 Median overall survival, combined with chemotherapy vs chemotherapy alone, in tumors with PD-L1 combined positive score ≥5 (hazard ratio 0.71). |
Malignant Pleural Mesothelioma
This is the approval that most clearly distinguishes this drug from other checkpoint inhibitors — it is the only PD-1 inhibitor combination approved as first-line treatment for unresectable malignant pleural mesothelioma.
| 18.1 vs 14.1 months | CheckMate-743 · NCT02899299 Median overall survival, combined with ipilimumab vs chemotherapy (hazard ratio 0.74). The benefit was larger in non-epithelioid tumors (hazard ratio 0.46) than in epithelioid tumors (hazard ratio 0.85). |
How Is It Given?
This is an intravenous infusion, given at a hospital or infusion center — not a tablet taken at home. Because the dose, schedule and combination partner all depend on the specific cancer and treatment line, the table below gives typical examples rather than an exhaustive list.
| Example regimen | Used in |
|---|---|
| 240 mg every 2 weeks, or 480 mg every 4 weeks, alone | Several single-agent uses across multiple cancers |
| 360 mg every 3 weeks, combined with chemotherapy | First-line NSCLC, urothelial carcinoma, esophageal and gastric cancers |
| Combined with ipilimumab on a separate schedule (often every 3 or 6 weeks) for a fixed number of doses, then continued alone | Melanoma, RCC, mesothelioma, HCC, colorectal cancer (MSI-H/dMMR) |
What Matters for a Patient
- The exact dose, interval and combination is decided by the treating oncologist based on the specific cancer, stage and prior treatment.
- Treatment often continues for up to two years, or until the disease progresses or side effects become unacceptable — the exact stopping point again depends on the cancer being treated.
- Doses are typically withheld or adjusted, rather than reduced, if side effects occur — ask your care team what their plan is if you feel unwell after an infusion.
Side Effects and Safety
The Main Safety Story: Immune-Mediated Side Effects
Because this drug works by releasing a brake on the immune system, that same immune system can turn against healthy tissue — the lungs, gut, liver, hormone glands, skin, kidneys, or other organs. These reactions are called immune-mediated adverse reactions, and they are the defining safety concern for this entire class of drug, not a rare footnote.
- New or worsening cough, shortness of breath, or chest tightness — possible lung inflammation (pneumonitis)
- Diarrhea, blood in the stool, or severe abdominal pain — possible immune-mediated colitis
- Yellowing skin or eyes, dark urine, or unusual tiredness — possible liver inflammation
- Extreme fatigue, weight change, headache, or feeling unusually cold or hot — possible thyroid or adrenal gland involvement
- Rash, blistering, or mouth sores — possible immune-mediated skin reaction
- Decreased urination or swelling — possible kidney inflammation
These reactions can appear at any point during treatment, and sometimes even after it has stopped. Blood tests to check liver enzymes, kidney function and thyroid hormones are done before starting and periodically throughout treatment specifically to catch these early. Most immune-mediated reactions are managed by pausing treatment and, if needed, giving corticosteroids — but severe cases can require permanently stopping treatment.
Other Things Worth Knowing
- Infusion reactions: reported in roughly 6% of patients receiving this as a single agent; most are mild and managed by slowing or pausing the infusion.
- Stem cell transplant: patients who go on to have an allogeneic stem cell transplant, before or after this treatment, face a higher risk of serious transplant-related complications — this is discussed specifically with your transplant team if relevant.
- Pregnancy: this drug can cause fetal harm. Effective contraception is advised during treatment and for a period after the last dose — your oncologist will specify how long for your regimen.
Common (Non-Immune) Side Effects
Reported in at least one in five patients, depending on whether it is used alone or in combination:
- Fatigue and general weakness
- Rash and itching
- Musculoskeletal pain and joint pain
- Diarrhea, nausea and decreased appetite
- Cough and shortness of breath
- Fever
To report a suspected side effect involving a product we supplied, use our adverse event reporting page. You can also report directly to your national regulator or to the marketing authorization holder.
Getting This Treatment: Access, Supply and India
Why Access Can Be Hard
This is a hospital-administered, prescription-only infusion, typically given in an oncology day-care unit. Where it is registered and reimbursed, that logistics chain is usually already in place. In many other countries, though, it may not be launched yet, may only be approved for some of its eleven indications, or the cost may be well beyond what a family can absorb without support.
How Ikris Pharma Network Can Help
Ikris Pharma Network is a pharmaceutical sourcing and supply company — we do not manufacture medicines. We help hospitals, pharmacies, importers and treating doctors reach hard-to-find oncology products through documented, regulated channels. Depending on the destination country, that can mean:
- Our Indian Generic Medicines service
- Our Named Patient Management service, for medicines not yet registered locally
- Guidance on the import route: read how named-patient imports work
- Other cancer medicines: see our oncology supply from India overview
Whether a particular brand can be supplied, and for which indication, depends on the destination country's rules, the patient's prescription and current availability. We confirm each case individually and never guess.
What to Have Ready When You Contact Us
- A prescription or letter from the treating oncologist, specifying the cancer type and treatment regimen
- Relevant biomarker reports (PD-L1, MSI-H/dMMR, or others as applicable)
- The destination country and any import license or permit your hospital holds
- The quantity needed and the delivery address or hospital pharmacy
A Word of Caution About Unverified Sellers
- Counterfeit and diverted cancer medicines do circulate online, and a price that looks too good to be true usually is.
- Injectable oncology products require unbroken cold-chain handling; buy only from suppliers who can document that.
- Be wary of anyone selling prescription oncology drugs without asking for a prescription first.
- Our trusted wholesale supplier guide explains what to look for.
Frequently Asked Questions
What cancers is this treatment used for?
Eleven cancer types currently carry FDA approvals: non-small cell lung cancer, melanoma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, MSI-H/dMMR colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric/gastroesophageal junction/esophageal adenocarcinoma, and malignant pleural mesothelioma. The exact approved setting (first-line, after surgery, after other treatment) differs by cancer.
Is this chemotherapy?
No. It is an immunotherapy — specifically a PD-1 checkpoint inhibitor. Rather than killing dividing cells directly the way chemotherapy does, it releases a brake on the patient's own immune system so T-cells can recognize and attack the tumor. It is sometimes combined with chemotherapy, but it is not chemotherapy itself.
Does it cure cancer?
In most approved settings, no trial has described it as a cure — the goal is longer disease control or longer survival. In a few adjuvant settings (after surgery, such as in melanoma, urothelial or esophageal cancer), it is used specifically to reduce the chance the cancer comes back, which is a different goal than treating existing metastatic disease.
How is it given?
As an intravenous infusion at a hospital or infusion center, typically every 2, 3 or 4 weeks depending on the regimen. It is not a tablet and cannot be taken at home.
What is the biggest safety concern?
Immune-mediated side effects, where the activated immune system attacks healthy organs — commonly the lungs, gut, liver, skin, kidneys or hormone glands. These can appear at any time during treatment or after stopping, which is why regular blood monitoring is part of routine care.
Why is it sometimes combined with another immunotherapy or with chemotherapy?
Combinations can produce a stronger response than either drug alone by attacking the tumor through more than one immune pathway, or by pairing immune activation with direct tumor cell killing. Combinations also generally carry a higher rate of side effects, so the specific pairing used depends on the approved indication for that cancer.
Do I need a biomarker test first?
It depends on the cancer. Some approvals require PD-L1 testing on the tumor; the colorectal cancer approval requires MSI-H or dMMR status specifically. Other uses do not require a biomarker test at all. Ask your oncologist which applies to your specific diagnosis.
How long does treatment continue?
It varies by cancer and setting — some regimens run for a fixed period (often up to two years), while others continue until the disease progresses or side effects become unacceptable. Your oncologist will specify the plan for your particular indication.
Can this be combined with targeted therapy?
Yes, in specific settings. In advanced renal cell carcinoma, it is approved in combination with the targeted drug cabozantinib as a first-line option.
What side effects are most common overall, apart from immune reactions?
Fatigue, rash, joint or muscle pain, itching, diarrhea, nausea, reduced appetite, cough and fever are the most frequently reported, whether used alone or in combination.
Is this the same as other checkpoint inhibitors like pembrolizumab?
They are in the same drug class (PD-1 inhibitors) and often used in similar clinical situations, but each has its own set of FDA-approved indications, trial data and dosing. They are not interchangeable without a specific reason, and the choice between them is made by the treating oncologist based on the approved indication for the cancer in question.
Can this be sourced from India for patients in other countries?
Often, yes — though it depends on the destination country's import rules, cold-chain logistics, the prescription on file, and whether the product is already registered there. Ikris Pharma Network coordinates the documentation and logistics. Share your country and requirement, and we will tell you what is realistic.
About Ikris Pharma Network
Ikris Pharma Network is an international pharmaceutical services company with offices in Noida (India), Sofia (Bulgaria) and Hong Kong. We source, supply and distribute hard-to-access medicines, with a focus on oncology and rare diseases. Learn more on our company page, or explore other targeted cancer therapies, such as olaparib for BRCA-mutated cancers or acalabrutinib for MCL, CLL and SLL.
Medical Disclaimer
This article is for general educational purposes and does not replace medical advice, diagnosis or treatment. This is a prescription-only medicine that must be administered and monitored by a qualified oncologist in a suitable clinical setting. Do not start, stop or change any treatment based on this page. Approvals, doses and safety information vary by country and are updated over time, so always check the current product label and speak to your doctor. See our full disclaimer.
Sources
Every dosing, safety and efficacy figure in this article is drawn from a single primary source:
Opdivo (nivolumab) Prescribing Information. Bristol Myers Squibb. U.S. Food and Drug Administration — label version effective August 12, 2026, retrieved from the FDA's openFDA drug label database. Sections referenced: Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, and Clinical Studies (Section 14).
Section 14 of the label lists most trials by their ClinicalTrials.gov identifier, included above next to each result for anyone who wants to look up a trial directly:
- CheckMate-067 (melanoma) — NCT01844505
- CheckMate-227 (NSCLC, first-line) — NCT02477826
- CheckMate-057 (NSCLC, previously treated) — NCT01673867
- CheckMate-743 (mesothelioma) — NCT02899299
- CheckMate-214 (RCC, first-line combination) — NCT02231749
- CheckMate-9ER (RCC, first-line combination) — NCT03141177
- SWOG S1826 / CA209-8UT (Hodgkin lymphoma) — NCT03907488
- CheckMate-141 (head and neck) — NCT02105636
- CheckMate-901 (urothelial, first-line) — NCT03036098
- CheckMate-274 (urothelial, adjuvant) — NCT02632409
- CheckMate-8HW (colorectal, MSI-H/dMMR) — NCT03143153
- CheckMate-9DW (hepatocellular) — NCT04039607
- CheckMate-577 (esophageal, adjuvant) — NCT02743494
- CheckMate-649 (gastric/GEJ/esophageal adenocarcinoma) — NCT02872116
Note: the FDA label text for CheckMate-648 (esophageal squamous cell carcinoma, first-line) lists the same NCT identifier as CheckMate-8HW, which appears to be a transcription error in that document; we have not been able to independently confirm CheckMate-648's correct identifier from this source, so it is cited here by name only.