Genmab Reports Results of Daratumumab Based Combination Therapy in P-III ANDROMEDA Study for Light-chain Amyloidosis
Shots:
- The P-III ANDROMEDA (AMY3001) study involves assessing of Daratumumab (SC) + cyclophosphamide + bortezomib + dexamethasone (CyBorD) vs CyBorD as monothx. in 388 patients newly diagnosed with AL amyloidosis, conducted by Janssen
- The P-III ANDROMEDA study resulted in meeting its 1EPs of the percentage of patients with hematologic complete response (53.3% vs 18.1%), the safety profile is in consistent with the known safety profile of the CyBorD regimen and the known safety profile of daratumumab
- In 2012, Genmab granted Janssen an exclusive WW license to develop, manufacture, and commercialize daratumumab. Janssen will discuss data with health authorities to prepare for regulatory filings
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