Nivolumab

Therapeutic indications

Nivolumab is indicated for:

Melanoma

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Nivolumab as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Non-small cell lung cancer

Population group: only adults (18 years old or older)

Nivolumab as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Renal cell carcinoma

Population group: only adults (18 years old or older)

Nivolumab as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Classical Hodgkin lymphoma

Population group: only adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Squamous cell cancer of the head and neck

Population group: only adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Urothelial carcinoma

Population group: only adults (18 years old or older)

Nivolumab as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Oesophageal squamous cell carcinoma

Population group: only adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Adjuvant treatment of oesophageal or gastro-oesophageal junction cancer

Population group: only adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Adjuvant treatment of muscle invasive urothelial carcinoma

Population group: only adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Adjuvant treatment of melanoma

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Melanoma

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Malignant pleural mesothelioma

Population group: only adults (18 years old or older)

Nivolumab in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Renal cell carcinoma

Population group: only adults (18 years old or older)

Nivolumab in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)

Population group: only adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Oesophageal squamous cell carcinoma

Population group: only adults (18 years old or older)

Nivolumab 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%.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Oesophageal squamous cell carcinoma

Population group: only adults (18 years old or older)

Nivolumab 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%.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Renal cell carcinoma

Population group: only adults (18 years old or older)

Nivolumab in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Neoadjuvant treatment of non-small cell lung cancer

Population group: only adults (18 years old or older)

Nivolumab 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%.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Gastric, gastro-oesophageal junction or oesophageal adenocarcinoma

Population group: only adults (18 years old or older)

Nivolumab 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.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Urothelial carcinoma

Population group: only adults (18 years old or older)

Nivolumab in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Nivolumab is contraindicated in the following cases:

Lactation

Lactation

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Factors such as age, gender, and health history are evaluated to create a personalized medication regimen.

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