Regulatory Affairs

FDA approves AbbVie and Roche's Venclexta-rituximab combo for CLL

PBR Staff Writer Published 11 June 2018

AbbVie has secured approval from the US Food and Drug Administration (FDA) for the combination of Venclexta (venetoclax tablets) and rituximab for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The approval for the drug regimen is for CLL and SLL patients, with or without 17p deletion, and who had received more than one prior therapy.

Venclexta is an oral BCL-2 inhibitor, which has been developed by AbbVie and Roche. Rituximab, on the other hand is an antibody therapy developed by Genentech, a subsidiary of Roche.

Approval of the drug regimen was driven by the results of a phase 3 trial called Murano in which it was shown to have significantly improved progression-free survival (PFS) for relapsed/refractory (R/R) CLL patients. The Venclexta-rituximab combination was also successful in cutting down the risk of disease progression or death by 81%.

The late-stage trial evaluated the Venclexta-rituximab regimen against bendamustine plus rituximab, which is a standard of care chemoimmunotherapy regimen.

Patients in the Venclexta-rituximab arm had recorded an overall response rate (ORR) of 92% which was 72% in the bendamustine plus rituximab arm.

AbbVie research and development executive vice president and chief scientific officer Michael Severino said: "VENCLEXTA now gives indicated patients a new opportunity to significantly reduce the risk of their disease progressing, compared to a current standard of care.

"This combination provides previously treated CLL or SLL patients with a chemotherapy-free, fixed duration treatment allowing patients the ability to stop treatment after approximately two years.

"This is an important step for patients and we look forward to continuing to provide new treatment options for people living with difficult-to-treat blood cancers."

The FDA has also approved Venclexta as a monotherapy for the treatment of chronic lymphocytic leukemia (CLL) in patients, with or without 17p deletion and who had least one prior therapy.


Image: AbbVie Corporate Headquarters. Photo: courtesy of AbbVie Inc.