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NICE rejects mycosis fungoides-type cutaneous T-cell lymphoma therapy over data concerns

pharmafile | August 5, 2020 | News story | Research and Development, Sales and Marketing Ledaga, NICE, lymphoma 

NICE has announced its rejection of Ledaga (chlormethine gel), a topical therapy for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL), a type of non-Hodgkin’s lymphoma.

The institute said it made the decision because it could not determine the efficacy of the therapy versus standard care. Flawed clinical trial design given as the reason for this lack of clarity, with no provided data directly comparing chlormethine gel to phototherapy, the current standard first-line treatment for the symptoms of MF-CTCL.

Cost-effectiveness estimates were also lacking in the application; while patients in this indication usually require multiple rounds of treatment to achieve relapse of skin symptoms, the data provided only provided cost-estimates for one round of treatment before relapse was achieved.

Matt Fellows

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