Opdivo is a cancer medicine used to treat the following: * melanoma, a type of skin cancer; * non\-small cell lung cancer (NSCLC), a type of lung cancer; * advanced renal cell carcinoma, a kidney cancer; * classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell); * squamous cell cancer of the head and neck (SCCHN); * urothelial cancer, a cancer of the bladder and urinary tract; * malignant pleural mesothelioma, a cancer of the lining of the lungs; * a kind of cancer of the colon or rectum (lower part of the gut) that is described as microsatellite instability high (MSI\-H) or mismatch repair deficient (dMMR); * squamous oesophageal cancer, a cancer of the oesophagus (the passage from mouth to stomach); * oesophageal cancer and gastro\-oesophageal junction cancer (cancer at the junction between the stomach and the oesophagus) after chemotherapy, radiotherapy and surgery; * gastric (stomach), gastro\-oesophageal junction or oesophageal adenocarcinoma; * hepatocellular carcinoma (HCC), a type of liver cancer, in previously untreated patients. The medicine is used in adults; for melanoma it is also used in adolescents from 12 years of age. Opdivo is mainly used when the cancer is advanced, unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body), or when other treatments do not work. For NSCLC that can be removed by surgery but is at high risk of coming back, Opdivo can also be given before surgery (neoadjuvant treatment) only, or both before surgery and afterwards to help prevent the cancer from coming back (neoadjuvant and adjuvant treatment). For melanoma, oesophageal cancer, gastro\-oesophageal junction cancer and urothelial cancer, Opdivo is also used as adjuvant treatment. For some cancers, Opdivo is only given to patients whose tumours produce certain levels of a protein known as PD\-L1 or are determined to be MSI\-H or dMMR. Opdivo can be used on its own and, for some cancers, it is also used together with other cancer medicines such as cabozantinib, ipilimumab or chemotherapy. Opdivo contains the active substance nivolumab.
Therapeutic Indication
**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 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. **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.
Therapeutic Area (MeSH)
ATC Code
L01FF01
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Opdivo
Medicine Name
Opdivo
Aliases
N/ANo risk management plan link.
