UK regulator approves ‘significant advance’ in CLL treatment


The National Institute for Health and Care Excellence (NICE) has approved a combination of Imbruvica (ibrutinib) and venetoclax for all untreated chronic lymphocytic leukaemia (CLL) patients in England.

The oral, fixed-duration combination treatment for adult CLL patients has been approved as first-line therapy and has been shown to be more effective than existing treatments.

NICE’s decision is based on clinical trial data showing significant benefits of using iburitnib and venetoclax instead of a current therapy, chlorambucil with obinutuzumab.

In the GLOW Phase III study, ibrutinib in combination with venetoclax reduced the risk of progression or death by 79% and showed an overall survival (OS) advantage over chemoimmunotherapy.

Study investigator Carsten Niemann, Clinical Associate Professor and Principal Investigator at Rigshospitalet, Copenhagen, Denmark, commented on the results: “This first all-oral, fixed-duration novel combination demonstrates an OS advantage in the first-line treatment of CLL and is an innovative option for patients.”

Leukaemia Care, the UKs leading leukaemia charity, submitted a written response to NICE representing the views of CLL patients by drawing on experiences and data, and advocating for untreated patients to have access to this new combination therapy.

Leukaemia Care’s CEO, Zack Pemberton-Whiteley said: “This approval could be one the most significant advances in CLL treatment in the last decade, avoiding chemotherapy treatment for many newly diagnosed patients”.

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