The US FDA is requiring that Amgen Inc. conduct randomized trials in adults and pediatric patients to confirm the clinical benefit of Blincyto (blinatumomab) in treating minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL) in what will likely contribute to forming a stringent dataset for the agency.
Amgen's Postmarketing Trials For Blincyto Likely To Form Stringent Dataset On Minimal Residual Disease
US FDA requiring randomized trials in adults and children as part of Blincyto’s supplemental accelerated approval in minimal residual disease; along with Amgen's data, agency will have results from NCI-funded trials to evaluate efficacy.