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news.The UK's National Institute for Health and Care Excellence (NICE) has issued a positive final appraisal determination (FAD) recommending Roche's Gazyvaro (obinutuzumab) for routine use on the National Health Service (NHS).
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The drug has been approved for use in combination with chlorambucil chemotherapy to treat adults with chronic lymphotic leukaemia (CLL).
Gazyvaro is indicated to treat adults who are previously untreated or have co-existing medical conditions that mean they are unsuitable for full dose fludarabine- or bendamustine-based therapy.
The company said that the positive determination comes eight months on from the granting of marketing authorisation for Gazyvaro in the UK.
The approval was based on data from the CLL11 trial involving eleven UK centres, which showed that Gazyvaro combined with chemotherapy reduced risk of death by 53%, meaning patients remained in remission more than 18 months longer than those receiving chemotherapy alone.
Additionally, more than one in five patients (22.3%) receiving Gazyvaro was in complete remission after treatment, contrasted to no patients in complete remission when receiving the current standard treatment, chemotherapy alone.
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 – at which point they will be responsible for making funding available so that clinicians and their patients can access the drug."
Gazyvaro is licensed by 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.