US FDA accepts for review a supplemental new drug application seeking approval of Bruton’s kinase inhibitor zanabrutinib for the treatment of Waldenstroms macroglobulinaemia

The application included data from a Phase III trial (ASPEN) comparing zanabrutinib to ibrutinib. The primary endpoint of superiority for complete response and very good partial response (VGPR) was not met, but a VGPR was achieved in more patients (28.4% v 19.2%).

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Biospace Inc.