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Daratumumab (darzalex) granted approval in EU, but rejected by NICE

May 11, 2017

Following the positive opinion issued by the European Medicines Agency’s ( EMA’s) Committee for Medicinal Products for Human Use( CHMP), Darzalex® (daratumumab) was granted full EU approval on April 28 th2017, to be used for the treatment of Multiple Myeloma (MM) patients that have received at least one prior therapy. Daratumumab can now be prescribed in combination with either lenalidomide and dexamethasone, or bortezomib and dexamethasone for this patient subset. The approval was based on data described from two pivotal clinical trials, described in a previous MMHub article. This approval extends the current EMA indication for Darzalex, which was approved for use as a monotherapy.

However, while EU patients can now celebrate, there was a negative decision in the UK by the National Institute for Health and Care Excellence(NICE). The appraisal consultation document published on 17 thMarch 2017 stated: ‘Daratumumab monotherapy is not recommended, within its marketing authorisation, for treating relapsed and refractory multiple myeloma in adults, that is, after therapy including a proteasome inhibitor and an immunomodulatory agent and whose disease has progressed on the last therapy.’  The committee cited limitations in the clinical-effectiveness data as a reason for this decision, which leaves UK patients lagging behind EU countries for treatment options. NICE will convene again for a second assessment and a final decision is expected in July this year.