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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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