The U.S. Food and Drug Administration granted priority review to a supplemental biologics license application to expand the use of its nivolumab to patients with previously treated Hodgkin lymphoma.
The application included data from the phase II CheckMate-205 study, which evaluated the safety and efficacy of nivolumab in patients with classic Hodgkin lymphoma who received autologous hematopoietic cell transplantation and brentuximab vedotin. Nivolumab previously received breakthrough therapy designation for this indication.
Nivolumab is indicated as a single agent for the treatment of patients with BRAF V600 wild-type and mutation-positive unresectable or metastatic melanoma, in combination with ipilimumab for the treatment of patients with unresectable or metastatic melanoma, for the treatment of patients with metastatic non–small cell lung cancer with progression on or after platinum-based chemotherapy, and for the treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy.
Source: Bristol-Myers Squibb press release, April 14, 2016.