The USFDA has given accelerated approval to combination therapy of daratumumab and hyaluronidase for the treatment of newly diagnosed light chain amyloidosis (AL) . The combination is approved for use with the fixed-dose regimen of bortezomib, cyclophosphamide, and dexamethasone . The approval was based on the evidence from the clinical trial ANDROMEDA (NCT 03201965). In the open-label, randomized, active-controlled trial, the efficacy of test drug combination was evaluated on 388 patients with the newly diagnosed disease and have at least one organ affected due to the disease.
The hematologic complete response (HemCR) rate produced by the test drug group was the primary outcome measured. The study results revealed that the test drug combination provided a 41.2 % HemCR rate compared to the 13.5 % rate produced using standard treatment. The dose recommended in the prescription manual is…
