The National Institute for Health and Care Excellence (NICE) has requested further evidence on Amgen’s Blincyto (blinatumomab) for the treatment of adults with acute lymphoblastic leukaemia.
The committee concluded that Blincyto has significant clinical benefits, but that further evidence on cost-effectiveness is required to assess its plausibility for NHS funding. NICE has requested further clarification from the company for the second committee meeting in April.
The drug first won conditional clearance for use in adults in November 2015, which was converted to full approval in June last year on the back of data from the Phase III TOWER study, in which it showed a superior improvement in median overall over standard of care chemotherapy (7.7 months versus four months, respectively).
Blincyto is an example of a BiTE antibody construct, a type of immunotherapy designed to help the body’s immune system to detect and target malignant cells. The modified antibodies engage two different targets simultaneously, thereby juxtaposing killer T cells to cancer cells to trigger apoptosis.
The drug is already licensed for treating adults with Philadelphia chromosome-negative CD19 positive B‑precursor acute lymphoblastic leukaemia, for people in first or second complete remission with minimal residual disease greater than 0.1%.
Last year European regulators expanded its scope to include the treatment of younger patients with the disease.
Acute lymphoblastic leukaemia is a rare and rapidly progressing cancer of the blood and bone marrow, with around 760 new cases in the UK a year, but as yet there is no widely accepted standard treatment regimen given to patients with relapsed or refractory ALL beyond chemotherapy.