The Food and Drug Administration (FDA) granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.), a subcutaneous formulation of daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.
This drug is the first and only approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.
Efficacy was evaluated in ANDROMEDA clinical trial (NCT03201965), an open-label, randomized, active-controlled trial in 388 patients with newly diagnosed AL amyloidosis with measurable disease and at least one affected organ according to consensus criteria. Patients were randomized to receive bortezomib, cyclophosphamide, and dexamethasone (VCd arm) or with daratumumab (D-VCd arm).
The hematologic complete response (HemCR) rate based on established consensus response criteria as evaluated by an independent review committee was 42.1% for the D-VCd arm and 13.5% for the VCd arm (odds ratio=4.8; 95% CI: 2.9, 8.1; p<0.0001).
Results on daratumumab for AL amyloidosis patients have been presented in different scientific congresses such as the European Hematology Association (EHA) Annual congress held in June 2020. Myeloma Patients Europe (MPE) interviewed Dr Moshe Gatt, Hadassah Hebrew University Medical Center, Jerusalem (Israel), and one of the authors of the ANDROMEDA study. Watch below this interview:
Read more information about the ANDROMEDA clinical trial here.
Read here the FDA announcement on daratumumab for AL amyloidosis patients.