Restrictions placed on Bristol-Myers Squibb studies investigating regimens combining Opdivo (nivolumab) with existing treatments for previously unresponsive multiple myeloma cases have been partially rescinded by the Food and Drug Administration (FDA).
The FDA had placed clinical holds on two studies examining the efficacy of the combinations, according to a Bristol-Myers Squibb announcement. The ruling lifting the limitations ensued after the company consulted with the FDA and agreed to protocol revisions. Patient enrollment will resume for two trials; a third trial remains on partial hold.
Relapsed or refractory multiple myeloma is a myeloma that has not proven responsive to therapy. Opdivo works by connecting to the body’s immune system to encourage anti-tumor reaction, the announcement said.
Opdivo became the first programmed death-1 (PD-1) immune checkpoint inhibitor to obtain regulatory approval internationally, according to the release. Now approved in over 60 counties, including the United States and Japan, the medication ranked among Bristol-Myers Squibb’s premier treatments for metastatic melanoma.
Bristol-Myers Squibb first attained the right to market Opdivo in most countries in 2011, the announcement said.