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The European Commission approves daratumumab as front-line treatment in newly diagnosed multiple myeloma
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The European Commission (EC) has approved a recent recommendation by the Committee for Medicinal Products for Human Use (CHMP) for use of daratumumab (Darzalex®) as first-line treatment for multiple myeloma (MM) patients (pts)1,2. Janssen’s daratumumab - in combination with bortezomib, melphalan, and prednisone (VMP) - has now gained approval by the EC for newly diagnosed (ND) MM pts who are ineligible for an autologous stem cell transplant (ASCT).
Authorization of daratumumab under this new indication is based on results from the ALCYONE study, a phase III, randomized, multi-center clinical trial with 706 participants, led by Dr Victoria Maria Mateos. The results of this study were published in the New England Journal of Medicine3 in February 2018 and presented at ASH 2017.
Daratumumab became available as front-line treatment in the US earlier this year, after approval by the Food and Drug Administration (FDA).
This approval provides NDMM pts in Europe, who are ineligible for an ASCT, with a new effective treatment combination.
- OncLive online. Daratumumab/VMP Combo Approved in EU for frontline Myeloma. https://www.onclive.com/web-exclusives/daratumumabvmp-combo-approved-in-eu-for-frontline-myeloma. [Assessed September 03 2018].
- PharmaTimes online. Janssen bags new EU approval for Darzalex. http://www.pharmatimes.com/news/janssen_bags_new_eu_approval_for_darzalex_1251100. [Assessed September 03 2018].
- Mateos M.V.et al. ALCYONE Trial Investigators. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. New England Journal of Medicine.2018 Feb 8; DOI:10.1056/NEJMoa1714678.
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