FDA lifts partial hold on Bristol-Myers myeloma med study

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The decision follows consultation with the FDA and agreement on amendments to the study protocol.

Three trials evaluating Opdivo-based combinations in relapsed or refractory multiple myeloma were placed on partial clinical hold in September 2017 as an FDA precaution following risks identified in trials studying another anti–PD-1 agent, pembrolizumab, in patients with multiple myeloma. CheckMate -602 is the last of the three trials to have its partial clinical hold lifted following a similar FDA action announced in December 2017, when the agency lifted partial holds on CA209-039 (CheckMate -039) and CA204-142.

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