The FDA has placed a partial hold on three clinical trials investigating nivolumab (Opdivo) based combination treatments in patients with relapsed or refractory multiple myeloma.
The announcement follows a couple of months after the discontinuation of two trials of another checkpoint inhibitor pembrolizumab (Keytruda) combined with other treatments in patients with multiple myeloma.
The FDA said in August they would be ‘working directly with sponsors of Keytruda® and other PD-1/PD-L1 cancer drugs, as well as clinical investigators conducting clinical trials in patients with multiple myeloma, to determine the extent of the safety issue.’
Nivolumab (Opdivo) manufacturer Bristol-Myers Squibb said in a statement that no new patients would be enrolled in the CheckMate-602, CheckMate-039 or CA204142 at this time.
However patients who were already enrolled and experiencing clinical benefit could continue with their treatment.
They said the FDA had determined the risks of PD-1/PD-L1 treatment plus pomalidomide or lenalidomide and possibly PD-1/PD-L1 treatments alone or with other combinations outweighed potential benefit for patients with multiple myeloma.
However studies of nivolumab outside of multiple myeloma would continue as planned, they said.
Nivolumab (Opvido) has recently been listed on the PBS for locally advanced or metastatic non-small cell lung cancer and advanced (stage IV) clear cell variant renal cell carcinoma.