US approval for Venclexta plus Rituxan for previously treated CLL

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The US FDA has approved Venclexta in combination with Rituxan for the treatment of people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), who have received at least one prior therapy.

Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and commercialised by AbbVie outside.

“We are pleased that this approval makes Venclexta, a first-of-its-kind targeted therapy, available for more people with chronic lymphocytic leukaemia whose disease has returned after previous treatment,” said Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development.

“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 approval is primarily based on the results of the phase III MURANO study, which were published online in the New England Journal of Medicine in March 2018.

The results showed that a fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death by 81% compared with bendamustine plus Rituxan, a current standard of care.

The approval converts Venclexta’s accelerated approval to a full approval. The FDA has also updated the indication for Venclexta as a single agent, which is now approved for the treatment of people with CLL or SLL, who have received at least one prior therapy.