The US FDA has shown a vote of confidence in using minimal residual disease (MRD) as a response endpoint with the accelerated approval of a supplemental indication for Amgen's Blincyto (blinatumomab) to treat adults and children with MRD-positive acute lymphoblastic leukemia (ALL).
FDA Grants Blincyto Accelerated Approval Based On MRD Response Endpoint
Amgen sees the approval as a platform to expand blinatumomab into other hematologic malignancies using similar approaches.
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