The FDA's partial clinical hold on a phase 3 study of Venetoclax was lifted thanks to an agreement to revisions to the CANOVA study protocol.
The CANOVA study protocol helps reduce risk and updates futility criteria. The venetoclax is used to treat relapsed/refractory multiple myeloma.
“We are pleased to move forward with the CANOVA study which, with the t(11;14) biomarker test, can help identify patients who may respond better to treatment and add clarity for physicians when choosing a therapy, if approved,” said Mohamed Zaki, global head of hematology development, AbbVie. “We are working closely with regulatory authorities worldwide to continue our efforts to understand the potential of venetoclax for patients with multiple myeloma while continuing to advance research in patients with the t(11;14) genetic abnormality.”
The removal of this hold does not change the status of any other trial evaluating venetoclax in patients with multiple myeloma nor does it change the approved indications for venetoclax like chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML).
