Opdivo (nivolumab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Bristol-Myers Squibb Pharma EEIG. Opdivo (nivolumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf. Revised June 2025. Accessed September 5, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	3
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%.	3
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.	1
OPDIVO in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.	2
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%.	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%	1
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.	6
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.	2
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 tumors have PD-L1 expression >= 1%.	4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
EMA (2)	MSI-H	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Ipilimumab, Nivolumab, Pemetrexed
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Ipilimumab, Nivolumab, Pemetrexed
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Ipilimumab, Nivolumab, Paclitaxel
EMA (2)	dMMR	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab
EMA (2)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Nivolumab, Paclitaxel
EMA (2)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Nivolumab, Pemetrexed
EMA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Gemcitabine, Nivolumab
EMA (1)	PD-L1 >= 1%	Bladder Urothelial Carcinoma	Nivolumab
EMA (1)	PD-L1 >= 1%	Esophageal Squamous Cell Carcinoma	Ipilimumab, Nivolumab
EMA (1)	PD-L1 >= 1%	Esophageal Squamous Cell Carcinoma	Cisplatin, Fluorouracil, Nivolumab
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Esophageal Adenocarcinoma	Fluorouracil, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Adenocarcinoma of the Gastroesophageal Junction	Fluorouracil, Nivolumab, Oxaliplatin
EMA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Nivolumab, Pemetrexed
EMA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Docetaxel, Nivolumab
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Stomach Adenocarcinoma	Capecitabine, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Esophageal Adenocarcinoma	Capecitabine, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Stomach Adenocarcinoma	Fluorouracil, Nivolumab, Oxaliplatin