Priority Review for Imbruvica-Gazyva combo to treat CLL, SLL

AbbVie Inc. (NYSE:ABBV) said FDA accepted and granted Priority Review to an sNDA for Imbruvica ibrutinib plus Gazyva obinutuzumab to treat chronic lymphocytic leukemia or small lymphocytic leukemia in the first-line setting.

AbbVie said the combination would be the first FDA-approved chemotherapy-free, anti-CD20 combination therapy for CLL or SLL. In May, AbbVie said the combination led to a progression-free survival benefit vs. Gazyva plus chlorambucil, meeting the primary endpoint in the Phase III iLLUMINATE trial to treat CLL and SLL (see "Imbruvica, Gazyva Combo Meets in First-Line CLL")...