FDA Approves Venclexta-Gazyva Combo as Frontline Treatment for CLL/SLL

The Food and Drug Administration (FDA) has approved the combination use of Venclexta (venetoclax) plus Gazyva (obinutuzumab) for the frontline treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The agency’s approval is based on findings from the phase 3 CLL14 trial, in which the combination reduced the risk of disease progression or death by 67% versus Gazyva plus Leukeran (chlorambucil) in patients with treatment-naïve CLL and co-existing medical conditions.

In the trial, the combination of fixed-duration Venclexta and Gazyva was compared with Gazyva and Leukeran in 432 treatment-naïve patients with CLL and coexisting medical conditions. Patients were randomized to receive 12 months of Venclexta alongside six months of Gazyva (arm A) or six months of Gazyva followed by 6 months of Leukeran (arm B).

The overall response rate was 85% with the combination, versus 71% in the control arm. The complete response or complete response with incomplete hematologic recovery rates were 50% versus 23%, respectively.

The rate of minimal residual disease (MRD)-negativity in the bone marrow was 57% with the addition of Venclexta compared with 17% in the Gazyva plus Leukeran arm. The MRD-negativity rates in the peripheral blood were 76% versus 35%, respectively.

“Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard of care,” Dr. Sandra Horning, chief medical officer and head of Global Product Development at Roche (Genentech), the drugs’ manufacturer, said in a press release.

Complete results of the study are scheduled to be presented early next month at the 2019 ASCO Annual Meeting.

This article originally appeared on OncLive as “FDA Approves Venetoclax/Obinutuzumab Combo for Frontline CLL.”