EU green light for Opdivo in blood cancer as new data show promising benefits

Breakthrough immunotherapy Opdivo (nivolumab) has been approved in the European Union for the treatment of classical Hodgkin lymphoma (cHL), a rare and often-aggressive blood cancer, said the drug’s maker, Bristol-Myers Squibb (NYSE: BMY).

Specifically, the approval is for patients whose cancer is progressing (relapsed or refractory) despite autologous stem cell transplantation (ASCT) and treatment with brentuximab vedotin (BV).At this advanced stage, Hodgkin lymphoma is a terminal condition with limited therapy options currently available.

The approval comes as new data presented at the American Society for Hematology (ASH) congress show that nearly 95% of patients in this setting, were still alive at one year. The primary endpoint of the study showed that considerable cancer reduction was seen in over two-thirds of patients on nivolumab (68%, 95% CI: 56%, 78%), measured as objective response rate (ORR). In addition, 8% (95% CI: 3%, 16%) of these patients saw a complete response (CR), where no recognisable sign of cancer remained.3 - the news today highlights nivolumab as an important new option for these patients.