The U.S. Food and Drug Administration (FDA) has granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed following autologous hematopoietic cell transplantation (HCT) and post-transplantation brentuximab vedotin.1
“Today’s approval of Opdivo delivers a transformational and exciting new option for these patients and the hematologists who treat them. By expanding this Immuno-Oncology therapy into a hematologic malignancy, we continue to deliver upon our unwavering commitment to provide treatments that work directly with the body’s immune system for patients who are in need of new options,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb.
Approval was based on findings from 2 multicenter, single-arm studies that evaluated the efficacy and safety of nivolumab in adults with relapsed or refractory classical Hodgkin lymphoma. Results showed that the overall response rate was 65% (95% CI, 55-75) among 95 patients previously treated with autologous HCT and post-transplantation brentuximab vedotin. A total of 7% achieved a complete remission and 58% had a partial remission. The estimated median duration of response was 8.7 months.
The most common adverse reactions in patients with classical Hodgkin lymphoma were fatigue, upper respiratory tract infection, pyrexia, diarrhea, and cough. Serious adverse events were reported in 21% of 263 evaluable patients with relapsed or refractory classical Hodgkin lymphoma.
Clinicians should also be aware that complications of allogeneic HCT may occur after treatment with nivolumab. Patients should be monitored closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions.
The recommended dose and schedule of nivolumab for classical Hodgkin lymphoma are 3 mg/kg administered intravenously every 2 weeks.
RELATED: ABVD, BEACOPP Demonstrate Similar Survival Advantage in Advanced-stage Hodgkin Lymphoma
This indication is the sixth for the programmed death receptor-1 (PD-1) blocking antibody, which is also approved for the treatment of advanced melanoma, metastatic non-small cell lung cancer, and advanced renal cell carcinoma.
- Opdivo® (nivolumab) granted first approval of a PD-1 inhibitor in hematology for the treatment of classical Hodgkin lymphoma patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin by the FDA [news release]. Princeton, NJ: Princeton, NJ; May 17, 2016. http://news.bms.com/press-release/cancer/opdivo-nivolumab-granted-first-approval-pd-1-inhibitor-hematology-treatment-cla. Accessed May 18, 2016.