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Amgen Will Try To Convince ODAC Of Minimal Disease Endpoint To Show Blincyto's Efficacy

 
• By Michael Cipriano

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. 

Leukemia cell (blast cell)

Amgen Inc. will need to convince the US FDA's Oncologic Drugs Advisory Committee that the surrogate endpoint minimal residual disease (MRD) response is predictive of a future clinical benefit, as the company is seeking a new indication for Blincyto (blinatumomab) to treat MRD-positive B-cell precursor acute lymphoblastic leukemia (BCP ALL).

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