On 29 January 2026, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended authorisation of BMS’s Opdivo® (nivolumab) in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.
Opdivo® has been approved in the EU for several other indications including a subcutaneous formulation for various solid tumours; non-small cell lung cancer; melanoma; gastric, gastroesophageal junction, or oesophageal adenocarcinoma; and in combination with Yervoy® for unresectable or advanced hepatocellular carcinoma; microsatellite instability–high or mismatch repair deficient unresectable or metastatic colorectal cancer.
A number of nivolumab biosimilars are in development, with Zydus recently being first to market its biosimilar, Tishtha®, in India. Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars in their pipelines.