Posted by Michael Wonder on 24 Feb 2017
CHMP issues positive opinion recommending Darzalex (daratumumab) for relapsed or refractory multiple myeloma
24 February 2017 - Opinion based on data from two Phase III studies, CASTOR and POLLUX.
Genmab announced today that the CHMP of the EMA has issued a positive opinion recommending broadening the existing marketing authorization for Darzalex (daratumumab) in the European Union.
he recommendation is for the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The variation to the marketing Authorisation for this indication was submitted to the EMA in August 2016.
In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
