Opdivo (nivolumab) given CHMP recommendation for approval in treatment for relapsed or refractory classical Hodgkin lymphoma- BMS

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Opdivo (nivolumab), from BMS. The CHMP adopted a new indication as follows: Opdivo is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.

Comment: in May 2016, the FDA approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin. This accelerated approval was based on overall response rate. Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trials.