FDA approves Darzalex Faspro for light chain amyloidosis
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The FDA granted accelerated approval to daratumumab plus hyaluronidase-fihj in combination with bortezomib, cyclophosphamide and dexamethasone for treatment of newly diagnosed light chain amyloidosis.
Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) — a subcutaneous formulation of daratumumab (Darzalex, Janssen) — is approved for several indications for which IV daratumumab already is authorized.
The FDA based the most recent indication on results of the randomized controlled ANDROMEDA trial, which included 388 patients with newly diagnosed light chain amyloidosis with measurable disease and at least one affected organ.
Researchers randomly assigned patients to bortezomib (Velcade, Takeda/Millennium), cyclophosphamide and dexamethasone with or without daratumumab plus hyaluronidase-fihj.
Results showed a higher hematologic complete response rate as assessed by independent review committee in the group assigned the experimental combination (42.1% vs. 13.5%; OR = 4.8; 95% CI, 2.9-8.1).
The most common adverse events among patients with light chain amyloidosis treated with daratumumab plus hyaluronidase-fihj in combination with bortezomib, cyclophosphamide and dexamethasone included upper respiratory tract infection, diarrhea, peripheral edema, constipation peripheral sensory neuropathy, fatigue, nausea, insomnia, dyspnea and cough.
Prescribing information includes a warning that serious or fatal cardiac adverse events have occurred among patients with light chain amyloidosis treated with combination.
The FDA approved this application under its Real-Time Oncology Review pilot program, designed to accelerate the delivery of effective and safe cancer treatments to patients.
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