Genmab - Janssen's Darzalex Wins Positive Opinion In Europe For Two New Indications

 

• Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended granting marketing authorization to Genmab A/S GMAB 1.47% and its partner Janssen Biotech Inc's Darzalex (daratumumab) subcutaneous for amyloidosis.
• The opinion is for daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone to treat adult patients with newly diagnosed systemic light-chain amyloidosis.
• The CHMP also issued a positive opinion recommending Darzalex SC in combination with pomalidomide and dexamethasone in pre-treated adult multiple myeloma patients.

https://www.benzinga.com/general/biotech/21/05/21239272/genmab-janssens-darzalex-wins-positive-opinion-in-europe-for-two-new-indications