Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 31 July 2018

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.

Full Prescribing information

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Fluid Management

Fluid Management

Are you up-to-date with the latest evidence of effective procedures for fluid management?

+ 2 more

Hereditary ATTR amyloidosis

Hereditary ATTR amyloidosis

Explore the pathophysiology, epidemiology and multi-system symptoms associated with hereditary ATTR amyloidosis, as well as how to achieve an early and accurate diagnosis.

Sleep Apnea

Sleep Apnea

Sleep apnea is a chronic condition characterised by recurrent interruptions in breathing throughout the sleep cycle. Learn about the two main types of sleep apnea and hear from experts as they present the latest research at the Sleep and Breathing conference (Marseille, 2019).

Load more

Related Content

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