U.S. Food and Drug Administration Lifts Partial Clinical Hold on Opdivo (nivolumab)-based Combination Study in Multiple Myeloma
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
FDA action removes partial hold on CheckMate -602, the last of holds previously placed on three Opdivo-based combination trials in relapsed or refractory multiple myeloma PRINCETON, N.J.--(BUSINESS WIRE)-- 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, pembroli
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