Articles tagged with: European Approval

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[ by | Nov 20, 2015 3:56 am | One Comment ]
Kyprolis Approved In Europe

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 …

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[ by | Aug 9, 2013 3:42 pm | 4 Comments ]
Pomalidomide Approved In Europe For Relapsed And Refractory Multiple Myeloma

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 …

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