FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

NICE Rejects J&J’s Darzalex Routine Use for Multiple Myeloma

Jan. 24, 2018

The National Institute for Health and Care Excellence would not recommend Johnson & Johnson’s Darzalex (daratumumab) for routine use in treating multiple myeloma in adults, suggesting it as a fourth-line treatment.

NICE opted to designate Darzalex as a last resort treatment, recommending it as a treatment within the Cancer Drug Fund for relapsed and refractory multiple myeloma in adults only if they have undergone three previous treatments and the conditions in the managed access agreement are followed.

The recommendation does not apply to patients who are currently being treated with Darzalex, and they may continue without change to funding arrangements until they and their physician decide to end the treatment.

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