FDA gives accelerated approval to Opdivo (nivolumab) for Hodgkin lymphoma- BMS

Bristol-Myers Squibb has announced the FDA has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin. This accelerated approval is based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This first approval of a PD-1 inhibitor for cHL patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is based on a combined analysis of data from the Phase II CheckMate -205 and the Phase I CheckMate -039 trials. Based on this analysis (n=95), Opdivo delivered a high response rate, with an objective response rate (ORR) of 65%. The percentage of patients with a complete response was 7%, and the percentage of patients with a partial response was 58%. Among responders, the duration of response was maintained over time for a median of 8.7 months.

The safety of Opdivo in cHL was evaluated in 263 adult patients from the CheckMate -205 and -039 trials. Among these patients serious adverse reactions occurred in 21% of patients. The most frequent serious adverse reactions reported in more than 1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. In the safety population, 4.2% discontinued treatment due to adverse reactions, and 23% of patients had a dose delay for an adverse reaction. In the subset of patients in the efficacy population, serious adverse reactions occurred in 27% of the patients. In CheckMate -205 and -039, among all patients and the subset of patients in the efficacy population, respectively, the most common adverse reactions (reported in at least 20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%).1 In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%).