Posted by Michael Wonder on 06 Nov 2020
Genmab announces that Janssen has submitted a Type II variation application to the European Medicines Agency for use of subcutaneous Darzalex (daratumumab) in patients with light-chain amyloidosis
5 November 2020 - Submission is based on data from the Phase 3 ANDROMEDA (AMY3001) trial.
Genmab announced today that Janssen has submitted a Type II variation application to the EMA for the subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of adult patients with light-chain amyloidosis.
