- 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