FDA Approval Summary: Nivolumab for the Treatment of Relapsed or Progressive Classical Hodgkin Lymphoma. (24th April 2017)

• Record Type: Journal Article
• Authors: Kasamon, Yvette L.; de Claro, R. Angelo; Wang, Yaping; Shen, Yuan Li; Farrell, Ann T.; Pazdur, Richard
• Is Part Of: Oncologist. Volume 22:Number 5(2017)
• Page Start: 585
• Page End: 591
• Publication Date: 2017-04-24
• Subjects: Nivolumab -- Hodgkin lymphoma -- Programmed death‐ligand 1 -- Programmed cell death 1 inhibitor; Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1634/theoncologist.2017-0004
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract : On May 17, 2016, after an expedited priority review, the U.S. Food and Drug Administration granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post‐transplantation brentuximab vedotin (BV). Nivolumab in cHL had been granted breakthrough therapy designation. Accelerated approval was based on two single‐arm, multicenter trials in adults with cHL. In 95 patients with relapsed or progressive cHL after autologous HSCT and post‐transplantation BV, nivolumab, dosed at 3 mg/kg intravenously every 2 weeks, produced a 65% (95% confidence interval: 55%–75%) objective response rate (58% partial remission, 7% complete remission). The estimated median duration of response was 8.7 months, with 4.6‐month median follow‐up for response duration. The median time to response was 2.1 (range: 0.7–5.7) months. Among 263 patients with cHL treated with nivolumab, 21% reported serious adverse reactions (ARs). The most common all‐grade ARs (reported in ≥20%) were fatigue, upper respiratory tract infection, cough, pyrexia, diarrhea, elevated transaminases, and cytopenias. Infusion‐related reaction and hypothyroidism or thyroiditis occurred in >10% of patients; other immune‐mediated ARs, occurring in 1%–5%, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. A new Warning and Precaution was issued for complications of allogeneic HSCT after nivolumab, including severe or hyperacute graft‐versus‐host disease, other immune‐mediated ARs, and transplant‐related mortality. Continued approval for the cHL indication may be contingent upon verification of clinical benefit in a randomized trial. Abstract : On May 17, 2016, after an expedited priority review, the U.S. Food and Drug Administration granted accelerated approval for nivolumab for the treatment of patients with classical Hodgkin L that has relapsed or progressed after autologous HSCT and post‐transplantation brentuximab vedotin. This was the first FDA application for a PD‐1 inhibitor in hematologic malignancies. A summary of the FDA review and approval is presented here.