Venclexta plus Rituxan approved by FDA for previously treated CLL

On 8 June 2018, the US Food and Drug Administration (FDA) granted approval of Genentech’s Venclexta (venetoclax) in combination with Rituxan (rituximab) for the treatment of people with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion.

The FDA approval was based on the successful results from the open-label, multicenter, randomized, phase III MURANO study (NCT02005471) that was presented as a late-breaking abstract at the 59th Annual Meeting & Exposition of the American Society of Hematology. This study demonstrated that venetoclax-rituximab (VR) was superior to bendamustine-rituximab (BR) due to prolonged PFS and also that this trend was consistent across the subgroup analyses. These results were published in the New England Journal of Medicine in March 2018.

Peter Hillmen, St James's University Hospital, Leeds, UK, discussed the results from the MRD kinetics of the MURANO study in an interview with Lymphoma Hub at the 2018 American Society of Clinical Oncology. He noted that "a key secondary endpoint was MRD eradication from peripheral blood." He said that after 9 months of therapy, "there was a much higher rate of MRD reduction with VR, 62%, compared with BR, 13%." He concluded that "MRD is an important endpoint in CLL as it shows that VR is a more effective therapy."