Amgen's Blincyto Doubles Survival In TOWER
The full data that led to Amgen Inc.'s Phase III TOWER study of Blincyto in acute lymphoblastic leukemia being stopped early in February have now been presented and show that treatment with the product nearly doubled overall survival. However, expectations were already high for the product and the data are unlikely to impact sales.
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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.
Postmarketing studies randomized to look at real world data sets could provide the key, Temple suggests; Amgen rep describes use of real world data to support approval of leukemia drug Blincyto.
Keeping Track: US FDA Approvals Binge Continues With Dupixent, Ocrevus And Zejula; Two CAR-T Are Under Review
The latest drug development news and highlights from our US FDA Performance Tracker.