AbbVie, Roche's Venclexta combination approved by FDA for previously treated patients with CLL, SLL

AbbVie and Roche on Friday said that the FDA has cleared Venclexta (venetoclax) in combination with Roche and Biogen's Rituxan (rituximab) for use in patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Roche's chief medical officer and head of global product development Sandra Horning said "Venclexta plus Rituxan provides a new chemotherapy-free option shown to help people live longer without their disease progressing compared to a standard-of-care therapy." 

The drugmakers noted that the approval of the combination regimen for previously treated patients with CLL was primarily backed by data from the Phase III MURANO study. In the trial, the results of which were announced last December, Venclexta in combination with Rituxan significantly lowered the risk of disease progression or death by 81 percent versus Teva's Treanda (bendamustine) plus Rituxan. 

FirstWord reports in this therapy area - KOL Insight Chronic Lymphocytic Leukaemia (CLL): Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more. 

The combination of Venclexta and Rituxan was granted a breakthrough therapy designation by the FDA in 2015 for the treatment of patients with relapsed or refractory CLL with a 17p deletion. The agency awarded Venclexta accelerated approval the following year for use in patients with CLL who carry the 17p deletion. "Today's FDA approval converts Venclexta's accelerated approval to a full approval," Roche noted. The BCL-2 inhibitor was given conditional approval in 2016 by the European Commission under the brand name Venclyxto for the treatment of patients with difficult-to-treat CLL. 

For related analysis, see ViewPoints: Venclexta/Rituxan combo looks well positioned for expanded use in R/R CLL, and Physician Views Poll Results – AbbVie, Roche will exit ASH with practice-changing data for Venclexta.


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