Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval for Patients with Newly Diagnosed Light Chain Amyloidosis

April 20, 2021 Auto Bot approval, Health Canada, Janssen, patients, receives, regulatory 0

Shots:

  • The approval is based on results from the P-III ANDROMEDA (AMY3001) study involves assessing the safety and efficacy of Darzalex (1800mg, SC, qw) + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis
  • The study showed higher hematologic response rate in ITT population (53% vs 18%), patients who received VCd, 74% patients were exposed to the regimen for 6mos. or longer, while 32% were exposed for longer than 1yr.
  • Darzalex SC is a CD38-directed mAb, became the first SC therapy to be approved in Canada for AL amyloidosis. Health Canada review was conducted under Project Orbis

Click here to­ read full press release/ article | Ref: Newswire Canada | Image: Ars Technica

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