The FDA has placed partial clinical holds on 3 trials assessing nivolumab (Opdivo)-based combinations in patients with relapsed/refractory multiple myeloma.
Paris-based biopharmaceutical company Cellectis is developing UCART123 as a treatment for BPDCN and AML. The company said in a press release that it is working with the FDA to resume the trials with an amended protocol, including a reduced dose of UCART123 cells.
1. FDA Alerts Healthcare Professionals and Oncology Clinical Investigators about Two Clinical Trials on Hold Evaluating KEYTRUDA® (pembrolizumab) in Patients with Multiple Myeloma. https://www.fda.gov/Drugs/DrugSafety/ucm574305.htm. Accessed August 31, 2017.
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