FDA Grants Nivolumab Accelerated Approval for Hodgkin Lymphoma
Opdivo approved for patients with relapsed or refractory classical Hodgkin lymphoma.
The FDA today approved the use of nivolumab (Opdivo) for the treatment of classical Hodgkin lymphoma (cHL) that either relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris).
The accelerated approval was based on trials that included adults with relapsed or refractory cHL.
Researchers evaluated efficacy in 95 adults who had prior treatment with autologous HSCT and post-transplantation Adcetris.
Nivolumab showed a 65% overall response rate. Researchers found that 58% of patients had a partial remission and 7% of patients had a complete remission.
The median time-to-response was 2.1 months and the estimated duration of response was 8.7 months, according to the study.
Researchers evaluated safety in 263 patients with relapsed or refractory cHL. Researchers found that the most common adverse reactions were fatigue, upper respiratory tract infection, cough, pyrexia, and diarrhea.
Transplant-related deaths occurred after complications from allogeneic HSCT after treatment with nivolumab. A “Warning and Precaution” was issued, however, as providers should monitor patients closely for signs of transplant-related complications.
Nivolumab was granted orphan drug status for the treatment of Hodgkin lymphoma and was granted breakthrough therapy designation, as well as priority review.