The Food and Drug Administration (FDA) has granted accelerated approval for Opdivo (nivolumab; Bristol-Myers Squibb) 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 Adcetris (brentuximab vedotin; Seattle Genetics). 

The FDA approval was based on data from 2 single-arm, multi-center trials of Opdivo in adults with relapsed or refractory cHL regardless of PD-L1 expression status on Reed-Sternberg cells. The primary efficacy endpoint was objective response rate (ORR) as assessed by an independent radiographic review committee. Other outcome measures included duration of response (DOR). 

Among the 95 patients evaluated for efficacy, treatment with Opdivo led to a 65% ORR (95% CI: 55%, 75%), with 58% of patients achieving partial remission and 7% achieving complete remission. The median time-to-response was 2.1 months (range 0.7-5.7 months) and the estimated DOR was 8.7 months. The most common adverse reactions among 263 patients with relapsed or refractory cHL were fatigue, upper respiratory tract infection, cough, pyrexia, and diarrhea. 

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The Opdivo labeling was updated with a new Warning and Precaution regarding complications of allogeneic HSCT after Opdivo use. Healthcare professionals are to closely monitor patients for early signs of transplant-related complications, such as hyperacute graft vs. host disease, severe acute graft vs. host disease, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions. The FDA is requiring additional studies on the safety of allogeneic HSCT after Opdivo. 

Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is already indicated for use in advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy; as a single agent for patients with unresectable or metastatic melanoma with disease progression following ipilimumab and, if BRAF V600 mutation (+), a BRAF inhibitor; in combination with ipilimumab for BRAF V600 wild-type, unresectable or metastatic melanoma; and metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Opdivo is available as a 10mg/mL strength per vial in 4mL, 10mL single-use vials.

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