Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 07 December 2017

Indication(s)

Melanoma
OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

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

Non-Small Cell Lung Cancer (NSCLC)
OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.

Renal Cell Carcinoma (RCC)
OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.

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 squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.

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.

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More information

Category Value
Agency product number EMEA/H/C/003985
Orphan designation No
Date First Approved 19-06-2015
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions