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%).
Source:
Biospace Inc.