Shots:

• The approval is based on two studies: COLUMBA (MMY3012- P-III) study and P-II PLEIADES (MMY2040) study- which involves assessing of subcutaneous daratumumab (1800 mg) with rHuPH20 2-000 U/mL- combination with either bortezomib- lenalidomide and dexamethasone (D-VRd) or bortezomib- melphalan and prednisone (D-VMP)
• In Feb 2019- results from COLUMBA study were announced- presented in oral sessions at the 2019 ASCO Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. Additionally- in Dec 2019- an update of the COLUMBA data as well as data from the PLEIADES study were presented during poster sessions at the 61st ASH Annual Meeting
• DARZALEX FASPRO is a fixed dose formulation administered every three to five minutes to patients with multiple myeloma in the US

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Ref: Globenewswire | Image: Janssen