Opdivo Now Approved for Classical Hodgkin Lymphoma Treatment

The FDA has approved Bristol-Myers Squibb’s nivolumab (Opdivo) for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris) treatment.

This approval was based on trials that demonstrated Opdivo’s high response rate and an objective response rate of 65%. The percentage of patients with a complete response in trials was 7%, while 58% had a partial response.

For those who responded to treatment, the duration of response was maintained for a median of 8.7 months.

“It is important to have new treatment options for patients with difficult-to-treat diseases who have exhausted the current available options,” stated Anas Younes, MD, medical oncologist and chief of lymphoma service at Memorial Sloan Kettering Cancer Center, in a press release. “Because of the unique pathology and biology of classical Hodgkin lymphoma, it makes sense from a scientific standpoint to investigate a PD-1 inhibitor. The recent clinical data with Opdivo in patients with classical Hodgkin lymphoma who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is encouraging and has the potential to impact our approach to treating these individuals in the future.”

Opdivo is also indicated for treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. It was initially approved in December 2014 for patients with unresectable or metastatic melanoma who no longer respond to other drugs.

Health care providers should be aware of some potential adverse events associated with Opdivo, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, and encephalitis.