Amgen's Blincyto Has 'Potential Benefit' For MRD ALL, But Approval Chances Remain Unclear
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.
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Keeping Track: AstraZeneca Wins Approval For Lumoxiti, AbbVie Expands Label For Venclexta With MRD Data, and FDA Delays Acorda's Inbrijia NDA
The latest drug development news and highlights from our US FDA Performance Tracker.
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.