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More Than CAR-T: Hematologic Oncology Pipeline Offers Rich Menu Of Possible Approvals

Executive Summary

Sponsors of established products like Amgen's Kyprolis and Blincyto and Bristol's Sprycel work to bulk up labeling with new indications while FDA reviews at least six novel agents for blood cancers.

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Breakthrough-designated oncologics used historical comparator data to determine efficacy threshold for pivotal Phase II studies supporting accelerated approval; Blincyto’s subsequent full approval offers validation with conventional controlled study. 

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The latest regulatory submission news and highlights from our US FDA Performance Tracker.

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