Bristol Myers Squibb has received two expanded U.S. approvals for Opdivo (nivolumab) combinations that establish additional immunotherapy options for classical Hodgkin lymphoma across pediatric and adult populations.
The FDA approved Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) for previously untreated stage 3 or 4 classical Hodgkin lymphoma in patients age 12 and older, according to a March 20 news release. The approval is based on results from the phase 3 SWOG 1826 trial, which showed a 58% reduction in the risk of disease progression or death compared with BV-AVD.
Separately, the agency approved Opdivo in combination with brentuximab vedotin for children age 5 and older, adolescents and young adults through age 30 with relapsed or refractory disease after one prior line of therapy. That decision was supported by data from the phase 2 CheckMate-744 trial.
Both indications mark firsts for immunotherapy in these settings and expand Opdivo’s reach across a broader spectrum of Hodgkin lymphoma patients, according to the release.
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