FDA puts partial hold on three Opdivo-based combination studies in myeloma

The US Food and Drug Administration has placed a partial clinical hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clinical trials investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma.

Opdivo is one of the best-selling products for the drug’s maker, Bristol-Myers Squibb (NYSE: BMY), whose shares dipped 2.07% to $59.87 in after-hours trading on Wednesday. Opdivo generated sales of $1.2 billion in the second quarter of 2017 compared to $840 million in the like year ago period.

This partial clinical hold is related to risks identified  in trials studying another anti–PD-1 agent, pembrolizumab, in patients with multiple myeloma. The FDA determined data currently available from non-Opdivo studies indicate the risks of PD-1/PD-L1 treatment plus pomalidomide or lenalidomide and possibly PD-1/PD-L1 treatments alone or with other combinations outweigh potential benefit for patients with multiple myeloma.