What Is Opdivo (Nivolumab) Immunotherapy? Which Cancers Is It Effective Against?
In this article
What is Opdivo (nivolumab)?
Opdivo (nivolumab) is an immunotherapy drug that releases the PD-1 "brake" that prevents the immune system from recognizing cancer cells. Since December 2014, it has received approval in the US for melanoma, lung, kidney, head and neck, stomach and esophageal, bladder, colon, and liver cancers, as well as Hodgkin lymphoma and mesothelioma. In Türkiye, it is licensed for 8 cancer types and has been reimbursed by SGK in 15 separate settings since July 2025.
- How it works: By binding to the PD-1 receptor on T cells, it prevents the tumor from hiding from the immune system. It is given alone or with ipilimumab, chemotherapy, or other drugs.
- Where it is used: In addition to advanced disease, it is approved for treatment before or after surgery in melanoma and lung, esophageal, and bladder cancers.
- How it is given: By a 30-minute intravenous infusion, usually 240 mg every 2 weeks or 480 mg every 4 weeks. A subcutaneous form (Opdivo Qvantig) is also available in the US, but not in Türkiye.
- Important: Immune-related inflammation may affect organs such as the bowel, lungs, liver, and thyroid. Call your team without delay for new diarrhea, cough, or shortness of breath.
Why does this matter?
Nivolumab is one of the drugs that ushered in the "immune checkpoint" era of cancer treatment. In metastatic melanoma and lung cancer, where life expectancy had previously been only a few months, some patients began to experience responses lasting for years. Today, nivolumab is used not only for advanced disease but also to reduce recurrence risk in cancers that can be treated surgically.
However, the drug does not work for every patient, indications and reimbursement conditions vary by country, and its side effects are entirely different from those of chemotherapy. Knowing when it is used, how it is monitored, and which symptoms require immediate medical attention is important for continuing treatment safely and effectively.
What is Opdivo, and how does it work?
Opdivo (nivolumab) is a fully human monoclonal antibody that binds to the PD-1 receptor on the surface of T cells. It prevents cancer cells from applying the immune system's brake through PD-L1, allowing T cells to attack the tumor again. It was developed by Bristol Myers Squibb and Japan's Ono and first approved in the US for melanoma in December 2014.
PD-1 is a "checkpoint" that prevents the immune system from overreacting. Normal tissues and many cancer cells carry a molecule called PD-L1. When PD-L1 binds to PD-1 on a T cell, it sends the T cell a "do not attack" signal. Nivolumab breaks this connection. PD-1 was discovered in 1992 in Prof. Tasuku Honjo's laboratory at Kyoto University; for this work, Honjo shared the 2018 Nobel Prize in Physiology or Medicine with James Allison.
Figure 1 · How does nivolumab work?
The PD-1/PD-L1 checkpoint and the brake released by the drug.
This mechanism does not work in every tumor; cancer cells can also hide from the immune system in other ways. PD-L1 levels, microsatellite instability (MSI-H), and tumor type are used to predict the likelihood of response. We explain the use of nivolumab with ipilimumab, which targets CTLA-4, in our article on the ipilimumab and nivolumab regimen.
Which cancers is Opdivo used for?
| Cancer | US (FDA) | Turkish SmPC | SGK reimbursement |
|---|---|---|---|
| Melanoma (advanced and postoperative) | Yes | Yes | Yes |
| Non-small cell lung cancer | Yes | Yes | Yes (in some settings) |
| Pleural mesothelioma (with ipilimumab) | Yes | Yes | Yes (non-epithelioid) |
| Kidney cancer | Yes | Yes | Yes |
| Classical Hodgkin lymphoma | Yes | Yes | Yes (relapsed/refractory) |
| Head and neck squamous cell cancer | Yes | Yes | Yes |
| MSI-H/dMMR colorectal cancer | Yes | Yes | Yes (later-line) |
| Esophageal, stomach, and gastroesophageal junction cancers | Yes (PD-L1 ≥1) | Yes | Yes (in some settings) |
| Bladder and urinary tract (urothelial) cancer | Yes | No | No |
| Liver cancer (with ipilimumab) | Yes | No | No |
| Small cell lung cancer | Withdrawn in 2020 | No | No |
FDA approval history
| Date | Approval |
|---|---|
| 22 December 2014 | Advanced melanoma (first approval) |
| 4 March 2015 | Squamous non-small cell lung cancer that has progressed after chemotherapy |
| 30 September 2015 | With ipilimumab for advanced melanoma with normal (wild-type) BRAF V600 |
| 9 October 2015 | Non-squamous non-small cell lung cancer that has progressed after chemotherapy |
| 23 November 2015 | Metastatic kidney cancer after treatment that inhibits blood vessel formation |
| 23 January 2016 | With ipilimumab for advanced melanoma regardless of BRAF status |
| 17 May 2016 | Classical Hodgkin lymphoma after stem cell transplantation and brentuximab vedotin |
| 10 November 2016 | Head and neck squamous cell cancer that has progressed after platinum treatment |
| 2 February 2017 | Urothelial cancer that has progressed after platinum treatment |
| 31 July 2017 | MSI-H/dMMR metastatic colorectal cancer after chemotherapy (aged 12 and over) |
| 22 September 2017 | Liver cancer after sorafenib; withdrawn in July 2021 |
| 20 December 2017 | Postoperative (adjuvant) treatment for melanoma with lymph node involvement or metastatic melanoma |
| 6 March 2018 | The option of 480 mg every 4 weeks and a 30-minute infusion |
| 16 April 2018 | With ipilimumab as first-line treatment for intermediate- or poor-risk kidney cancer |
| 10 July 2018 | With ipilimumab for MSI-H/dMMR colorectal cancer after chemotherapy |
| 16 August 2018 | Third-line small cell lung cancer; withdrawn in December 2020 |
| 10 March 2020 | With ipilimumab for liver cancer after sorafenib |
| 15 May 2020 | With ipilimumab as first-line treatment for PD-L1 ≥1%, EGFR/ALK-negative metastatic non-small cell lung cancer |
| 26 May 2020 | With ipilimumab and 2 cycles of chemotherapy as first-line treatment for metastatic non-small cell lung cancer |
| 10 June 2020 | Esophageal squamous cell cancer after chemotherapy |
| 2 October 2020 | With ipilimumab as first-line treatment for unresectable pleural mesothelioma |
| 22 January 2021 | With cabozantinib as first-line treatment for advanced kidney cancer |
| 16 April 2021 | With chemotherapy as first-line treatment for stomach, gastroesophageal junction, and esophageal adenocarcinoma (the first immunotherapy for stomach cancer) |
| 20 May 2021 | Adjuvant treatment for esophageal/gastroesophageal junction cancer with residual disease after chemoradiotherapy and surgery |
| 19 August 2021 | Postoperative (adjuvant) treatment for urothelial cancer at high risk of recurrence |
| 4 March 2022 | With chemotherapy as preoperative (neoadjuvant) treatment for resectable non-small cell lung cancer |
| 18 March 2022 | Opdualag (nivolumab + relatlimab) for advanced melanoma |
| 27 May 2022 | Two first-line regimens for esophageal squamous cell cancer (with chemotherapy or ipilimumab) |
| 13 October 2023 | Postoperative treatment for stage IIB/IIC melanoma (aged 12 and over) |
| 6 March 2024 | With cisplatin and gemcitabine as first-line treatment for urothelial cancer |
| 3 October 2024 | Preoperative and postoperative (perioperative) treatment for non-small cell lung cancer |
| 27 December 2024 | Opdivo Qvantig: subcutaneous nivolumab (with hyaluronidase) for most solid tumor indications |
| 8 April 2025 | With ipilimumab as first-line treatment for MSI-H/dMMR colorectal cancer |
| 11 April 2025 | With ipilimumab as first-line treatment for liver cancer |
| May 2025 | First-line use in stomach/esophageal cancer restricted to tumors with PD-L1 ≥1 |
| 20 March 2026 | With AVD chemotherapy for previously untreated stage III-IV classical Hodgkin lymphoma (aged 12 and over) |
We discuss some of these approvals in separate articles: dual immunotherapy in lung cancer, mesothelioma, stomach cancer and liver cancer. We summarize the general role of preoperative immunotherapy in this article.
How is Opdivo administered?
| Use | Dose and interval |
|---|---|
| Alone (most indications) | 240 mg every 2 weeks or 480 mg every 4 weeks |
| Melanoma, with ipilimumab | First 4 doses: nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks; then nivolumab alone |
| Lung cancer, with ipilimumab | 360 mg every 3 weeks + ipilimumab 1 mg/kg every 6 weeks (with chemotherapy for the first 2 cycles if needed) |
| Preoperative lung cancer treatment | 360 mg + platinum-based chemotherapy every 3 weeks for 3 cycles |
- Administration: Given as a 30-minute intravenous infusion in a day treatment unit.
- Duration: In advanced disease, until progression or unacceptable side effects (up to 2 years for some indications); usually 1 year for postoperative treatment.
- Subcutaneous form: Opdivo Qvantig, approved in the US, is injected under the skin of the abdomen or thigh over a few minutes. It is not licensed in Türkiye.
What are the side effects of Opdivo?
According to the US product information, the most common side effects (at least 20%) with nivolumab alone are fatigue, rash, musculoskeletal pain, itching, diarrhea, nausea, weakness, cough, shortness of breath, constipation, loss of appetite, back and joint pain, upper respiratory tract and urinary tract infections, fever, headache, abdominal pain, and vomiting.
The main concern is immune-related side effects, which occur when the immune system also attacks healthy organs. These can appear at any time during treatment, even months after treatment has ended. They are more common and more severe when nivolumab is used with ipilimumab.
| Organ | Symptoms |
|---|---|
| Bowel (colitis) | Diarrhea, abdominal pain, blood or mucus in the stool |
| Lungs (pneumonitis) | New or worsening cough, shortness of breath, chest pain |
| Liver (hepatitis) | Yellowing of the skin or eyes, dark urine, pain in the upper right abdomen |
| Endocrine glands | Thyroid: weakness, weight change; pituitary: headache, extreme fatigue; diabetes: excessive thirst, frequent urination |
| Kidneys (nephritis) | Reduced urine, blood in the urine, swollen feet |
| Skin | Rash, itching; rarely a severe rash with fluid-filled blisters |
Figure 2 · What to do about side effects?
An action plan according to the severity of immune-related symptoms.
Most immune-related side effects can be controlled with corticosteroids when identified early; a doctor may add drugs such as infliximab for severe colitis that does not respond to corticosteroids or mycophenolate for severe liver inflammation. Consult your team before starting medicines for fever or pain on your own. We explain management in detail in our article on immunotherapy side effects.
What monitoring is performed during treatment?
- Before each administration: Complete blood count, liver and kidney tests, blood glucose.
- At regular intervals: Thyroid tests (TSH, free T4) and cortisol if needed.
- Imaging: CT, MRI, or PET-CT before treatment and usually every 8-12 weeks. With immunotherapy, a tumor may look larger on the first scan and then shrink (pseudoprogression), so your oncologist interprets the findings.
Opdivo in Türkiye: licensing, price, and SGK reimbursement
| Product | Retail price |
|---|---|
| Opdivo 40 mg/4 mL vial | 20,449.69 TL |
| Opdivo 100 mg/10 mL vial | 51,124.29 TL |
| One 240 mg cycle (2 × 100 + 1 × 40 mg) | 122,698.27 TL |
| One 480 mg cycle (4 × 100 + 2 × 40 mg) | 245,396.54 TL |
- Licensed indications: The SmPC includes 8 cancer types: melanoma, non-small cell lung cancer, pleural mesothelioma, kidney cancer, classical Hodgkin lymphoma, head and neck cancer, MSI-H colorectal cancer, and esophageal/stomach/gastroesophageal junction cancers. Bladder and liver cancer indications are not licensed in Türkiye. Opdualag and the subcutaneous form are not available in Türkiye.
- SGK: With the SUT amendment of 10 July 2025, nivolumab became reimbursable in 15 separate settings. It is prescribed by medical oncology specialists with a medical board report valid for up to 3 months and including a medical oncology specialist; each report renewal must state that the disease has not progressed. The age limit of 65 for kidney cancer was removed in January 2026.
| Cancer | Settings reimbursed by SGK (summary) |
|---|---|
| Melanoma | First-line treatment alone or with ipilimumab; postoperative treatment for stage III/IV for up to 12 months |
| Kidney | With ipilimumab as first-line treatment for intermediate/poor risk; alone after anti-VEGF therapy |
| Lung (non-small cell) | Alone after chemotherapy; first-line with ipilimumab and 2 cycles of chemotherapy for PD-L1 <50%; 3 preoperative cycles for stage IIIA, PD-L1 ≥1% |
| Mesothelioma | With ipilimumab as first-line treatment for non-epithelioid disease, for up to 24 months |
| Stomach, gastroesophageal junction, esophageal adenocarcinoma | HER2-negative, PD-L1 CPS ≥5, with first-line chemotherapy, for up to 24 months |
| Esophageal squamous cell cancer | Second-line treatment after chemotherapy |
| Other | Head and neck cancer relapsing within 6 months of platinum; MSI-H colorectal cancer after chemotherapy; Hodgkin lymphoma after transplantation and brentuximab |
We announced the reimbursement news for second-line use in lung cancer in February 2022 in this article. Prices are from the record dated 31 August 2026 and may change.
Frequently asked questions
- Is Opdivo chemotherapy?
- No. Opdivo does not directly kill the cancer cell; it is an immunotherapy that releases the immune system's brake so it can attack the tumor. It is given with chemotherapy for some cancers. Its side effects are also different from those of chemotherapy.
- When does Opdivo start to work?
- Response is usually assessed on the first scan within 2-3 months. With immunotherapy, a tumor may sometimes initially look larger and then shrink, so decisions are not based on a single scan.
- How long does Opdivo treatment last?
- In advanced disease, it continues until progression or serious side effects, with a limit of 2 years in some uses. Postoperative preventive treatment usually lasts 1 year, and preoperative treatment is given for 3 cycles.
- Is Opdivo covered by SGK?
- Yes. Since July 2025, it has been reimbursed under specific conditions with a medical board report for melanoma, lung, kidney, stomach and esophageal, head and neck, and colorectal cancers, mesothelioma, and Hodgkin lymphoma. There is no reimbursement for bladder or liver cancer.
Glossary
- PD-1 / PD-L1
- The PD-1 receptor on T cells and the PD-L1 molecule on cells; a checkpoint that suppresses the immune response when they bind together.
- MSI-H / dMMR
- Tumors with a faulty DNA repair system; they generally respond well to immunotherapy because they carry many mutations.
- Immune-related side effect
- Inflammation caused by the immune system attacking healthy organs (such as colitis, pneumonitis, hepatitis, or thyroiditis).
DROZDOGAN Academy Commentary
Over more than a decade, nivolumab has become one of oncology's most widely used drugs, with more than 30 FDA decisions.
⚡ Why it matters
It has produced long-lasting responses in melanoma and lung cancer; it is now also used before and after surgery to increase cure rates.
✅ Current evidence
Survival and disease-free survival improved in many phase 3 trials. In 2026, it was approved with chemotherapy for first-line Hodgkin lymphoma.
⚠️ Limitations
Some patients do not respond. Approvals for small cell lung cancer and single-agent treatment of liver cancer were withdrawn after confirmatory trials failed. Benefit is limited in stomach cancer with low PD-L1.
🩺 What to do in practice
- Before treatment, discuss tests such as PD-L1, MSI.
- If you develop new diarrhea, cough, or weakness, call the same day.
- In the emergency department, tell staff that you are receiving immunotherapy.
- Do not miss your thyroid and blood sugar checks.
❓ Open questions
The optimal treatment duration, better biomarkers to predict response, and the arrival of the subcutaneous form in Türkiye remain unclear.
Our brief judgment: Nivolumab is a key immunotherapy that can provide long-term control in the right patient. Early recognition of immune-related side effects is the key to safe use.
- This article was prepared in October 2026. Indications, dosing, and side effect information are based on the August 2026 version of the US product information; FDA dates on FDA, ASCO Post, ONS, and drugs.com records; and information for Türkiye on the Opdivo SmPC, SUT amendments of 10 July 2025 and 17 January 2026, and drug price databases.
- Information that could not be verified: Some FDA dates could only be confirmed through drugs.com (a press release may be dated a day later); the exact day of the PD-L1 restriction in 2025; whether the SUT amendment of 29 August 2026 affects nivolumab; entries for nivolumab on the TİTCK off-label list; and the regulatory basis for lung cancer reimbursement in February 2022.
- The diagrams and Academy commentary are our own. This article is not personal medical advice.
References
- Bristol Myers Squibb. OPDIVO (nivolumab) prescribing information, 08/2026. packageinserts.bms.com
- Opdivo FDA approval history. drugs.com
- FDA. Opdivo approvals for early-stage NSCLC, 2022. fda.gov
- FDA. Nivolumab with chemotherapy for previously untreated Hodgkin lymphoma, 2026. fda.gov
- FDA. Nivolumab and hyaluronidase-nvhy subcutaneous injection. fda.gov
- Nivolumab + ipilimumab BRAF V600 wild-type melanoma. ASCO Post, 2015. ascopost.com
- Nivolumab indication in small cell lung cancer withdrawn. ASCO Post, 2021. ascopost.com
- BMS statement on Opdivo monotherapy post-sorafenib HCC U.S. indication, 2021. news.bms.com
- FDA approves nivolumab for adjuvant treatment of urothelial carcinoma. ASCO Post, 2021. ascopost.com
- FDA approves nivolumab with cisplatin and gemcitabine for urothelial carcinoma. ASCO Post, 2024. ascopost.com
- FDA limits pembrolizumab and nivolumab in PD-L1-low stomach cancers. Oncology News Central, 2025. oncologynewscentral.com
- The Nobel Prize in Physiology or Medicine 2018. nobelprize.org
- Opdivo SmPC. ilacprospektusu.com
- SUT amendment, Official Gazette 10.07.2025, issue 32952. lexpera.com.tr
- SUT amendment, Official Gazette 17.01.2026. saglikaktuel.com
- Opdivo 100 mg price information. ilacrehberi.com
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