Takeda has announced the National Institute for Health and Care Excellence (NICE) recommendation of its advanced cutaneous T-cell lymphoma (CTCL) drug Adcetris (brentuximab vedotin).
The indication is for treating adult patients with CD-30 positive advanced versions of the disease, after at least one prior systemic therapy. The approval is due to close collaborative working between Takeda, the clinical and patient community, as well as NICE and NHS England.
The treatment already has European approval based on an open-label Phase III ALCANZA trial. The results showed that a single dose provided a statistically significant improvement compared to current treatment methods such as the control arm of methotrexate or bexarotene. Median progression-free survival was 16.7 months compared to 3.5 months with methotrexate or bexarotene.
Jon Neal, managing director UK & Ireland, Takeda, said: “We are really pleased NICE has approved brentuximab vedotin for patients with the most debilitating forms of CTCL. During the appraisal process, the Takeda team, together with the clinical and patient community, were able to convey to NICE the immense impact end-stage disease has on quality of life and the potential brentuximab vedotin has in improving clinical and quality of life outcomes. This means patients can now gain routine access via the NHS and clinical practice can be aligned to guideline recommendations.”
The drug is an antibody-drug conjugate (ADC) that specifically targets human CD30+ tumour cells, consisting of three components: the monoclonal antibody cAC10 specific for human CD30, the anti-microtubule agent monomethyl auristatin E (MMAE) and a protease-cleavable linker that covalently attaches MMAE to cAC10.