The U.S. Food and Drug Administration has approved nivolumab (Opdivo) in combination with chemotherapy (AVD) to treat adults and children aged 12 and older with advanced classical Hodgkin lymphoma who have not received prior treatment. The drug was also fully approved for adults whose disease has returned or not responded after stem cell transplant or multiple prior treatments.
The approval is based on a large clinical trial comparing nivolumab plus AVD with another standard regimen. Results showed that patients receiving nivolumab had better outcomes, with a significantly lower risk of disease progression. After about three years, 91% of patients on the nivolumab combination were free from disease progression, compared to 82% in the comparison group. Fewer deaths were also reported in the nivolumab group.
The benefits were seen across different age groups, including younger, adolescent, and older patients.
In terms of safety, about 39% of patients experienced serious side effects, while immune-related side effects were less common.
This approval provides a new first-line treatment option and may improve long-term outcomes for patients with advanced Hodgkin lymphoma.