CLL

The National Institute for Health and Care Excellence (NICE) has recommended Swiss drug-maker Roche’s Gazyvaro (obinutuzuma) to treat chronic lymphocytic leukaemia (CLL).

NICE has issued a positive final appraisal determination (FAD) for the new blood cancer drug for routine use within the NHS, including England and Wales.

It was recommended for use in combination with chlorambucil chemotherapy to treat previously-untreated adult patients with CLL and co-existing medical conditions who are unsuitable for full-dose fludarabine-based therapy, and only if bendamustine-based therapy is also not suitable.

Roche UK general manager Jayson Dallas said: "We are very pleased to have worked with NICE to reach a solution whereby patients will soon be able to routinely access Gazyvaro on the NHS in England and Wales.

"The priority is to ensure that commissioners are prepared for the publication of final guidance to follow."

"The priority is to ensure that commissioners are prepared for the publication of final guidance to follow, at which point they will be responsible for making funding available so that clinicians and their patients can access the drug."

The NICE recommendation was based on granting of marketing authorisation for Gazyvaro in the UK.

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Gazyvaro is the first glycoengineered Type II anti-CD20 monoclonal antibody licenced to treat CLL, and is designed by scientists through modification of specific sugars in the antibody to attack blood cancers more aggressively than Type I anti-CD20s.

It received approval from the European Medicines Agency (EMA) in combination with chlorambucil to treat previously untreated adult patients with CLL and co-existing medical conditions who are unsuitable for full-dose fludarabine-based therapy.


Image: Chronic lymphocytic leukaemia. Photo: courtesy of Erhabor Osaro.