FDA grants regular approval for Venclexta in CLL and SLL

11 June 2018

On June 8, 2018, the Food and Drug Administration granted regular approval to Venclexta (venetoclax) in combination with Rituxan (rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

According to Roche (ROG: SIX) subsidiary Genentech, which is developing Venclexta in cooperation with AbbVie (NYSE: ABBV), this approval is important because:

Venclexta plus Rituxan provides a new fixed duration, chemotherapy-free option for people with previously treated CLL and SLL and has been shown to significantly improve progression free survival (PFS) compared to a standard of care – based primarily on the results of the Phase III MURANO study.
CLL is the most common type of leukemia among adults. It is considered incurable and becomes harder to treat each time it returns.
The FDA has also converted Venclexta’s accelerated approval to a full approval. Venclexta was previously granted accelerated approval in April 2016 as a single agent for the treatment of people with CLL with 17p deletion.

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