The European Commission has approved venetoclax as part of a combination regimen for patients with previously-untreated Chronic Lymphocytic Leukemia (CLL).

Under the terms of the approval, venetoclax can now be used in combination with obinutuzumab, according to a press release from the manufacturer.

The approval comes after the completion of the Phase 3 CLL14 trial, which showed superior results for the combination therapy for progression-free survival as well as higher rates of undetectable minimal residual disease compared to obinutuzumab and chlorambucil.

Results of the CLL14 trial showed the 36-month PFS estimate for patients taking venetoclax and obinutuzumab was 81.9% [95% CI: 76.5, 87.3]. For patients in the obinutuzumab and chlorambucil arm, the 36-month PFS estimate was 49.5% [95% CI: 42.4, 56.6].

After one year of treatment, patients in the venetoclax arm experienced what the release described as a “deep response,” which was measured by several factors including undetectable minimal residual disease or complete response.

“Having the option to utilize a first-line, chemotherapy-free treatment combination that can produce a deep response, thus allowing patients to stop treatment, will change the way we treat CLL and have a significant impact on patients," Michael Hallek, MD, director of the Department of Internal Medicine and Center of Integrated Oncology at the University Hospital of Cologne, said in the release.

Venetoclax has already been approved as a treatment for adult patients with CLL who have had at least one prior therapy in combination with rituximab. It is also approved as a monotherapy for adult patients with the presence or absence of 17pdeltion or TP53 mutation who are unsuitable or have failed with a B-cell receptor pathway inhibitor, the release said.

By Adam Hochron