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标 题: 强生的 Darzalex Faspro获批用于治疗 Rare Light Chain Amyloidosis
发信站: BBS 未名空间站 (Tue Jan 19 00:30:56 2021, 美东)
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The U.S. Food and Drug Administration (FDA) approved Janssen Pharmaceuticals
’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly
diagnosed light chain amyloidosis.
subcutaneous formulation of daratumumab. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). It is the first and only FDA-approved therapy for patients with this indication. It was
developed with Genmab. The two companies entered a global development,
manufacture and commercialization deal in August 2021. Darzalex Faspro is
the only CD38-directed antibody that has been approved for subcutaneous
injection for multiple myeloma, and now AL amyloidosis. It is co-formulated