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Amgen's Blincyto Has 'Potential Benefit' For MRD ALL, But Approval Chances Remain Unclear

 
• By Michael Cipriano

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.

Question

The US FDA's Oncologic Drugs Advisory Committee (ODAC) said Amgen Inc.'s Blincyto (blinatumomab) has a "potential benefit" for patients with minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL), but the approval prospects for the supplemental indication remain unclear, as the vote should not be viewed as a vote in favor of approval.

ODAC specifically voted 8 to 4 that Amgen's single-arm, Phase II pivotal trial demonstrates "that for patients with ALL in CR who have MRD > 0

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