More Than CAR-T: Hematologic Oncology Pipeline Offers Rich Menu Of Possible Approvals
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.
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.
Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
The latest regulatory submission news and highlights from our US FDA Performance Tracker.