The European Commission (EC) has approved nivolumab (Opdivo®)in combination with brentuximab vedotin for the treatment of adult and pediatric patients with relapsed or refractory classical Hodgkin Lymphoma (cHL). This indication applies to children ages 5 years and older, adolescents, and adults up to 30 years of age who have received one prior line of therapy.
In its press release, BMS reported that the decision was based on results from the phase 2 CheckMate -744 study, which evaluated the risk-based, response-adapted regimen in younger patients. Data from the trial demonstrated that the combination achieved high complete metabolic response rates, allowing many patients to proceed to consolidation therapy while maintaining a manageable safety profile.
The FDA also approved nivolumab in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients who are 12 years and older and have previously untreated stage III or IV classical Hodgkin lymphoma, at the same time of the EU approval.
