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

  Ref: Newswire Canada | Image: Janssen