EU approves Opdivo (nivolumab) for classical Hodgkin lymphoma (cHL).- BMS

Bristol-Myers Squibb's Opdivo has become the first PD-1/PD-L1 inhibitor to secure approval for classical Hodgkin lymphoma (cHL). The EMA approved Opdivo (nivolumab) for adult patients with cHL who have previously received an autologous stem cell transplant and treatment with Adcetris (brentuximab vedotin) – the current standard of care. The FDA approved the drug for the same indication in May 2016.

The approval is based on data from the phase II CheckMate-205 trial and the phase I CheckMate-039 study, which found that two-thirds of patients treated with Opdivo had an objective response. In 6% of cases the cancer was completely destroyed, with the remaining 60% experiencing a partial response.