FDA News

FDA approves Venclexta-Gazyva regimen for untreated chronic lymphocytic leukemia

Sandra Horning, MD
Sandra Horning

The FDA approved venetoclax in combination with obinutuzumab for patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Venetoclax (Venclexta; AbbVie, Genentech) selectively binds and inhibits the BCL-2 protein. Obinutuzumab (Gazyva, Genentech) is an anti-CD20 monoclonal antibody.

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 [with] a standard of care,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “[This] approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukemia.”

The FDA based the approval on results of the randomized phase 3 CLL14 study, which included 432 patients with treatment-naive CLL and coexisting medical conditions.

Researchers randomly 216 patients to 12 months of venetoclax along with 6 months of obinutuzumab. The other 216 patients received 6 months of obinutuzumab plus chlorambucil, followed by an additional 6 months of chlorambucil.

The trial met its primary endpoint of improved PFS among patients assigned the venetoclax-obinutuzumab combination (HR = 0.33; 95% CI, 0.22-0.51).

A higher percentage of patients assigned venetoclax-obinutuzumab achieved response (85% vs. 71%; P = .0007), complete response or complete response with incomplete hematologic recovery (50% vs. 23%; P < .0001), minimal residual disease negativity in the bone marrow (57% vs. 17%; P < .0001) and peripheral blood (76% vs. 35%; P < .0001).

Median OS had not been reached in either treatment group.

The combination exhibited a safety profile consistent with the known profiles of each agent alone. The most common adverse reactions included low white blood cell count, diarrhea, fatigue, nausea, low red blood cell count and upper respiratory tract infection.

Full results of the study will be presented at ASCO Annual Meeting, which will be held May 31 to June 4 in Chicago.

Sandra Horning, MD
Sandra Horning

The FDA approved venetoclax in combination with obinutuzumab for patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Venetoclax (Venclexta; AbbVie, Genentech) selectively binds and inhibits the BCL-2 protein. Obinutuzumab (Gazyva, Genentech) is an anti-CD20 monoclonal antibody.

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 [with] a standard of care,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “[This] approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukemia.”

The FDA based the approval on results of the randomized phase 3 CLL14 study, which included 432 patients with treatment-naive CLL and coexisting medical conditions.

Researchers randomly 216 patients to 12 months of venetoclax along with 6 months of obinutuzumab. The other 216 patients received 6 months of obinutuzumab plus chlorambucil, followed by an additional 6 months of chlorambucil.

The trial met its primary endpoint of improved PFS among patients assigned the venetoclax-obinutuzumab combination (HR = 0.33; 95% CI, 0.22-0.51).

A higher percentage of patients assigned venetoclax-obinutuzumab achieved response (85% vs. 71%; P = .0007), complete response or complete response with incomplete hematologic recovery (50% vs. 23%; P < .0001), minimal residual disease negativity in the bone marrow (57% vs. 17%; P < .0001) and peripheral blood (76% vs. 35%; P < .0001).

Median OS had not been reached in either treatment group.

The combination exhibited a safety profile consistent with the known profiles of each agent alone. The most common adverse reactions included low white blood cell count, diarrhea, fatigue, nausea, low red blood cell count and upper respiratory tract infection.

Full results of the study will be presented at ASCO Annual Meeting, which will be held May 31 to June 4 in Chicago.

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