Amgen Will Try To Convince ODAC Of Minimal Disease Endpoint To Show Blincyto's Efficacy
US FDA unconvinced that minimal residual disease finding is predictive of clinical benefit, but Amgen's quest for new Blincyto indication to treat minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia can get boost if Oncology Drugs Advisory Committee supports the primary endpoint.
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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.
Amgen sees the approval as a platform to expand blinatumomab into other hematologic malignancies using similar approaches.
US FDA's oncology advisory committee seems to feel Blincyto has potential in minimal residual disease-positive acute lymphoblastic leukemia, but panel was not asked specifically about approval; a decision could hinge on how agency reviewers interpret committee's comments.