OncologyDrug intelligence

Opdivo

Nivolumab

PD-1 immune checkpoint inhibitor. Developed by Bristol Myers Squibb. Clinical, regulatory, and source evidence are connected below.

Company: Bristol Myers Squibb
Target / MOA: PD-1 · PDCD1
Aliases: Opdivo · ONO-4538 · BMS-936558

Signals: 23
Clinical trials: 16
Approvals: 2
Evidence sources: 23

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialOct 20, 2026ClinicalTrials.gov

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

Phase 2 · RECRUITING · National Cancer Institute (NCI)

clinical trialOct 20, 2026ClinicalTrials.gov

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer

Phase 2 · RECRUITING · Gilead Sciences

clinical trialOct 20, 2026ClinicalTrials.gov

Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers

Phase 2 · ACTIVE_NOT_RECRUITING · Dana-Farber Cancer Institute

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Opdivo · BLA125554 · label version 68, effective Aug 12, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. 1.2 Adjuvant Treatment of Melanoma OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.3 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). 1.4 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO as adjuvant treatment after surgery. 1.5 Metastatic Non-Small Cell Lung Cancer • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations. • OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations. • OPDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. 1.6 Malignant Pleural Mesothelioma OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.7 Advanced Renal Cell Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC. • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. 1.8 Classical Hodgkin Lymphoma • OPDIVO, in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). • OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after: • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. 1.9 Squamous Cell Carcinoma of the Head and Neck OPDIVO is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 1.10 Urothelial Carcinoma OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC [see Clinical Studies (14.10) ] . OPDIVO, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 1.11 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) . • OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 1.12 Hepatocellular Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.13 Esophageal Cancer • OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). • OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] . • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] . • OPDIVO is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. 1.14 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .

Opdivo Qvantig · BLA761381 · label version 9, effective May 12, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Advanced Renal Cell Carcinoma OPDIVO QVANTIG™, as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC) following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy. 1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. 1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.4 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). 1.5 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO QVANTIG as monotherapy in the adjuvant setting after surgical resection. 1.6 Metastatic Non-Small Cell Lung Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO QVANTIG. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. 1.7 Squamous Cell Carcinoma of the Head and Neck OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 1.8 Urothelial Carcinoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO QVANTIG, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following treatment with intravenous nivolumab and ipilimumab combination therapy. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater, with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. 1.10 Hepatocellular Carcinoma • OPDIVO QVANTIG, as monotherapy, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) following treatment with intravenous nivolumab and ipilimumab combination therapy. • OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib following treatment with intravenous nivolumab and ipilimumab combination therapy . Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable or metastatic HCC. 1.11 Esophageal Cancer OPDIVO QVANTIG as monotherapy, is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO QVANTIG, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.2) ] . Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. OPDIVO QVANTIG as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. 1.12 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO QVANTIG, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.2) ] .

European Union (EMA)

Opdivo · EMEA/H/C/003985 · Authorised, authorised Jun 19, 2015 (Commission decision C(2015) 4299) · EPAR

Melanoma Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1). Non-small cell lung cancer (NSCLC) Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLC Opdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Neoadjuvant and adjuvant treatment of NSCLC Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria). Malignant pleural mesothelioma (MPM) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Renal cell carcinoma (RCC) Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1). Classical Hodgkin lymphoma (cHL) Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma. Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Opdivo in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy (see section 5.1). Squamous cell cancer of the head and neck (SCCHN) Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1). Urothelial carcinoma Opdivo in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Opdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. Adjuvant treatment of urothelial carcinoma Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC (see section 5.1). Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings:- first-line treatment of unresectable or metastatic colorectal cancer;- treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. Opdivo in combination with fluoropyrimidine‑ and platinum‑based combination chemotherapy is indicated for the first‑line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD‑L1 expression ≥ 1%. Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine‑ and platinum‑based combination chemotherapy. Adjuvant treatment of oesophageal or gastro‑oesophageal junction cancer (OC or GEJC) Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro‑oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (see section 5.1). Gastric, gastro‑oesophageal junction (GEJ) or oesophageal adenocarcinoma Opdivo in combination with fluoropyrimidine‑ and platinum‑based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD‑L1 with a combined positive score (CPS) ≥ 5. Hepatocellular carcinoma (HCC) Opdivo in combination with ipilimumab is indicated for the first‑line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.

EMA's summary; the full indication is in the product information on the EPAR page.

Not covered here: Opdualag (BLA761234) (A combination of nivolumab and relatlimab; combination products are not covered yet.) BLA125527 (Opdivo) and BLA761429 (Opdivo Qvantig) (Not on the current Opdivo and Opdivo Qvantig labels.)

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

BLA125554 · BRISTOL MYERS SQUIBB · first approved Dec 22, 2014

65 efficacy supplements approved

Mar 20, 2026 · supplement 135
May 23, 2025 · supplement 133
Apr 11, 2025 · supplement 129
Apr 8, 2025 · supplement 132
Oct 3, 2024 · supplement 127
Mar 6, 2024 · supplement 125
Jan 26, 2024 · supplement 122
Oct 13, 2023 · supplement 121
Feb 15, 2023 · supplement 119
Feb 15, 2023 · supplement 118
Feb 15, 2023 · supplement 117
Jul 14, 2022 · supplement 114
May 27, 2022 · supplement 106
May 27, 2022 · supplement 105
May 11, 2022 · supplement 108
Mar 4, 2022 · supplement 112
Aug 19, 2021 · supplement 97
Jul 15, 2021 · supplement 99
May 20, 2021 · supplement 92
Apr 16, 2021 · supplement 91
Jan 22, 2021 · supplement 90
Oct 2, 2020 · supplement 89
Sep 18, 2020 · supplement 85
Sep 18, 2020 · supplement 84
Jun 10, 2020 · supplement 81
May 26, 2020 · supplement 82
May 15, 2020 · supplement 80
Mar 10, 2020 · supplement 78
Apr 18, 2019 · supplement 70
Mar 7, 2019 · supplement 42
Aug 16, 2018 · supplement 67
Jul 10, 2018 · supplement 63
Apr 16, 2018 · supplement 58
Mar 5, 2018 · supplement 66
Mar 5, 2018 · supplement 65
Mar 5, 2018 · supplement 64
Mar 5, 2018 · supplement 62
Mar 5, 2018 · supplement 61
Mar 5, 2018 · supplement 52
Mar 5, 2018 · supplement 51
Mar 5, 2018 · supplement 50
Mar 5, 2018 · supplement 49
Mar 5, 2018 · supplement 48
Feb 15, 2018 · supplement 45
Feb 15, 2018 · supplement 44
Jan 9, 2018 · supplement 39
Jan 9, 2018 · supplement 38
Jan 9, 2018 · supplement 37
Jan 9, 2018 · supplement 36
Jan 9, 2018 · supplement 35
Dec 20, 2017 · supplement 55
Sep 22, 2017 · supplement 41
Jul 31, 2017 · supplement 34
Apr 25, 2017 · supplement 31
Feb 2, 2017 · supplement 24
Nov 10, 2016 · supplement 22
Oct 4, 2016 · supplement 16
Sep 13, 2016 · supplement 18
Sep 13, 2016 · supplement 17
May 17, 2016 · supplement 19
Jan 23, 2016 · supplement 7
Nov 23, 2015 · supplement 12
Nov 23, 2015 · supplement 1
Oct 9, 2015 · supplement 5
Sep 30, 2015 · supplement 2

BLA761381 · BRISTOL-MYERS SQUIBB · first approved Dec 27, 2024

3 efficacy supplements approved

Nov 24, 2025 · supplement 5
Oct 27, 2025 · supplement 2
Oct 27, 2025 · supplement 1

European Union

Opdivo: Authorised since Jun 19, 2015

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

BLA125554 (Purple Book)

Orphan exclusivity until Apr 13, 2031

BLA761381 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

The current US labels have no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 16 linked records.

Phase 2RECRUITINGNCT06203600

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

National Cancer Institute (NCI) · Updated Oct 20, 2026

Phase 2RECRUITINGNCT07527858

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer

Gilead Sciences · Updated Oct 20, 2026

Phase 2ACTIVE NOT RECRUITINGNCT04416568

Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers

Dana-Farber Cancer Institute · Updated Oct 20, 2026

Phase 2TERMINATEDNCT03274258

Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma

M.D. Anderson Cancer Center · Updated Oct 20, 2026

Phase 3RECRUITINGNCT05675410

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

National Cancer Institute (NCI) · Updated Oct 20, 2026

Phase 1COMPLETEDNCT06542731

An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer

Ono Pharmaceutical Co., Ltd. · Updated Oct 20, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

Aug 12, 2026 · FDA

OPDIVO

May 12, 2026 · FDA

OPDIVO QVANTIG

Date unavailable · Swissmedic - Medical Devices & SaMD

Out-of-Stock – Opdivo 100 mg/10 ml, Konzentrat zur Herstellung einer Infusionslösung

Related intelligence

Connected drugs

Records connected through the current intelligence graph.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 20, 202620 FDAofficial · Latest Aug 12, 20262 Swissmedic - Medical Devices & SaMDofficial · Latest Date unavailable1

Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.