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Bristol-Myers Gets Positive CHMP Opinion For Empliciti

Bristol-Myers Squibb Co. (BMY) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion on a Type-II variation application for Empliciti or elotuzumab plus pomalidomide and low-dose dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy.

The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

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