The European Com­mis­sion has approved Darzalex (dara­tu­mu­mab) for the treat­ment of multiple myeloma.

The approval means that, for the first time, myeloma patients in Europe will be able to be treated with Darzalex without having to enroll in a clin­i­cal trial.

The European Darzalex approval is for use of the drug as a single agent – meaning Darzalex by itself, with no other anti-myeloma ther­apy – in adults with re­lapsed and refractory multiple myeloma. Patients must have been pre­vi­ously treated with a pro­te­a­some inhibitor and with an immun­o­modu­la­tory agent, and …

The Euro­pean Com­mis­sion has approved Empliciti (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma.

The ap­prov­al means that myeloma patients in Europe will now be able to be treated with Empliciti without having to en­roll in a clin­i­cal trial.

Empliciti's Euro­pean ap­prov­al comes on the heals of its ap­prov­al late last No­vem­ber in the United States, the mar­ket in which the drug re­ceived its first ever regu­la­tory ap­prov­al. As in the United States, Empliciti has been approved in Europe for use in com­bi­na­tion with Revlimid (lena­lido­mide) and dexa­meth­a­sone.

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The European Commission has approved Kyprolis (car­filz­o­mib) for the treat­ment of multiple myeloma.

The approval means that, for the first time, myeloma patients in Europe will be able to be treated with Kyprolis without having to enroll in a clinical trial.

Although Kyprolis was approved in the United States more than three years ago, the Phase 2 clinical trial that was the basis for that approval was not sufficient for a European approval. Additional data from a larger Phase 3 clinical trial had to be collected for …

The European Commission (EC) has approved pomalidomide for the treatment of certain patients with multiple myeloma.  The European brand name for the drug is expected to be "Imnovid," although final regu­la­tory approval of that name is still pending.

In the United States, pomalidomide is marketed under the brand name Poma­lyst.  It was approved earlier this year by the U.S. Food and Drug Ad­min­is­tra­tion (FDA) as a new treatment for myeloma.

The EC approved Imnovid for use in combination with dexamethasone (Decadron) in patients with …