FDA Grants Venetoclax NDA Priority Review for CLL
Genentech announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for venetoclax for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, including those with 17p deletion.
The NDA submission is based in part on data from the pivotal M13-982 study, an open-label, single-arm, multicenter Phase 2 trial evaluating the efficacy and safety of venetoclax in 107 patients with relapsed, refractory or previously untreated CLL with 17p deletion. The primary endpoint was overall response rate (ORR) as determined by an independent review committee (IRC).
Results showed that venetoclax achieved an ORR of 79.4% among the 107 patients with relapsed or refractory disease, meeting the study's primary endpoint. In addition, 7.5% of patients achieved a complete response with or without complete recovery of blood counts in the bone marrow (CR/CRi). Detailed findings were recently presented at the 57th American Society of Hematology (ASH) Annual Meeting.
Genentech, in collaboration with AbbVie, is evaluating venetoclax in a robust development program as a single agent or in combination with other therapies for the treatment of CLL and other hematologic cancers, including indolent non-Hodgkin's lymphoma (NHL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), and multiple myeloma (MM).
Venetoclax is an investigational, selective, small molecule inhibitor of the BCL-2 protein.
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