Shots:

• The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib- cyclophosphamide- and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed (AL) amyloidosis
• The study resulted in meeting its 1EPs overall hematologic complete response rate. The sBLA is being reviewed under the FDA’s RTOR program and reviewed under Project Orbis
• Darzalex Faspro is approved as the only SC CD38-directed Ab for MM and is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) and Halozyme's ENHANZE drug delivery technology

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