[Editorial] Patient need, drug development, and risk

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On March 21, 2019, the US FDA suspended all clinical trials investigating the use of venetoclax—a BCL-2 inhibitor—for the treatment of patients with relapsed or refractory multiple myeloma. The decision was based on interim results of the phase 3 BELLINI trial, which showed an increased risk of death for patients who were treated with venetoclax and bortezomib compared with placebo (41 [21·1%] deaths in 194 patients in the venetoclax group vs 11 [11·3%] of 97 in the control group; hazard ratio 2·03 [95% CI 1·04–3·94]).

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