Genmab: Janssen gets FDA OK for amyloidosis med

 

• DARZALEX FASPRO^® (daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis
• Accelerated approval of DARZALEX FASPRO-based combination regimen supported by the Phase 3 ANDROMEDA (AMY3001) study
• Genmab to receive USD 30 million milestone payment on first commercial sale

https://www.globenewswire.com/news-release/2021/01/15/2159577/0/en/Genmab-Announces-that-Janssen-has-been-Granted-U-S-FDA-Approval-for-DARZALEX-FASPRO-daratumumab-and-hyaluronidase-fihj-for-Patients-with-Newly-Diagnosed-Light-chain-AL-Amyloidosis.html