NICE says ‘yes’ to new blood cancer drug

Patients in England and Wales with chronic lymphocytic leukaemia (CLL) could soon benefit from Gazyvaro, after the National Institute for Health and Care Excellence (NICE) issued a positive Final Appraisal Determination (FAD) today recommending the drug for routine use on the NHS. Gazyvaro has been recommended for use in combination with chlorambucil chemotherapy for the treatment of 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.² This positive determination comes eight months on from the granting of Marketing Authorisation for Gazyvaro in the UK.³

Data from the main trial of the drug (CLL11), which involved eleven UK centres, showed that Gazyvaro, combined with chemotherapy, reduced the risk of death by 53% (HR 0.47 95% CI 0.29–0.76, p=0.0014),⁴ and meant that patients remained in remission more than 18 months longer than those receiving chemotherapy alone (median progression free survival (PFS) 29.9 months versus 11.1 months, HR 0.18, CI 0.14-0.24, p<0.0001).⁴ In addition, more than one in five (22.3%) patients receiving Gazyvaro was in complete remission after treatment.⁵ In contrast, no patients achieved complete remission when receiving the current standard, chemotherapy alone.⁵

“The treatment of CLL has greatly improved over the last ten years, although there still remains a significant unmet need in terms of treatment of the elderly and patients with other health conditions such as diabetes and heart disease which make them unsuitable to receive the most aggressive treatments,” said Professor John Gribben, Professor of Medical Oncology at Barts Cancer Institute, London. “The long-awaited decision from NICE to approve Gazyvaro, the first new treatment to show a survival advantage compared to chlorambucil chemotherapy alone, addresses the need for a tolerable and effective treatment option for these patients and is important for both clinicians and their patients in the fight against this common form of blood cancer.”

Jayson Dallas, General Manager, Roche UK, 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 has been shown to have a manageable tolerability profile when used in combination with chemotherapy.⁵  The most common adverse events associated with Gazyvaro in the CLL11 study were infusion-related reactions (IRRs).⁵ 21% of patients experienced a severe IRR, however no severe IRRs were observed after the first full dose of treatment.⁵ Other severe adverse events reported were neutropenia (35%), low platelet count (thrombocytopenia) (11%), infections (11%), anaemia (5%), leukopenia (5%).⁵

1. http://www.macmillan.org.uk/Cancerinformation/Cancertypes/
   Leukaemiachroniclymphocytic/AboutCLL/Wha tisCLL.aspx Last accessed: March 2015.
2. NICE FAD guidance for Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia. March 2015. 
3. Gazyvaro (obintuzumab). Summary of Product Characteristics. Available via http://www.medicines.org.uk/emc/ Last accessed: March 2015.
4. Goede V et al. Obinutuzumab as frontline treatment of chronic lymphocytic leukaemia: updated results of the CLL11 study. Leukaemia 2015; 1-3.
5. Goede V et al. Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions. New Eng J Med 2014; 370: 1101-1110.
6. http://www.cancerresearchuk.org/prod_consump/groups/cr_common
   /@cah/@gen/documents/generalconten/about-cll.pdf Last accessed: March 2015.