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FDA Approves Daratumumab–Hyaluronidase Plus VCd for AL Amyloidosis
On January 15, 2021, the FDA approved daratumumab plus hyaluronidase (Darzalex Faspro; Janssen Biotech) combined with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of patients with newly diagnosed light chain (AL) amyloidosis.
This application was granted accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
The efficacy of daratumumab plus hyaluronidase combined with VCd (D-VCd) was assessed in the open-label, active-controlled ANDROMEDA clinical trial. In this study, 388 patients with newly-diagnosed AL amyloidosis, measurable disease, and at least 1 affected organ according to consensus criteria were randomized to receive VCd or D-VCd.
Findings demonstrated hematologic complete response rates of 42.1% and 13.5% for the D-VCd and VCd arms, respectively (odds ratio, 4.8; 95% CI, 2.9-8.1; P <.0001).
The most common (≥20%) adverse events among recipients of the D-VCd regimen with AL amyloidosis are upper respiratory tract infection, diarrhea, peripheral edema, constipation peripheral sensory neuropathy, fatigue, nausea, insomnia, dyspnea, and cough.—Hina Porcelli
Source: US Food and Drug Administration. FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis. January 15, 2021. www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis. Accessed January 15, 2021.
