Accelerated Approval Granted for Newly Diagnosed Light Chain Amyloidosis Treatment

Accelerated approval was granted on January 15, 2021, by the US Food and Drug Administration (FDA) for daratumumab plus hyaluronidase human-fihj in combination with dexamethasone, bortezomib, and cyclophosphamide for newly diagnosed light chain amyloidosis (AL).

Results from ANDROMEDA, an open-label, randomized, active-controlled trial, were the basis of the efficacy evaluation. Patients (N = 388) with newly diagnosed AL with measurable disease and at least 1 affected organ according to consensus criteria were included in the study and randomized to receive treatment with either bortezomib, cyclophosphamide, and dexamethasone (VCd arm) or with VCd in combination with daratumumab plus hyaluronidase human-fihj (D-VCd arm).

Based on recognized criteria of consensus response that were evaluated by an independent review committee, the hematologic complete response rate was 42.1% for the D-VCd arm and 13.5% for the VCd arm, P <.0001.

Warnings and precautions regarding serious or fatal cardiac adverse reactions occurring in patients with AL who have been treated with the combination of daratumumab plus hyaluronidase human-fihj with bortezomib, cyclophosphamide, and dexamethasone are included in the prescribing information. It is not recommended to treat patients with AL who have New York Heart Association class IIIB or class IV cardiac disease or Mayo stage IIIB disease with daratumumab plus hyaluronidase human-fihj outside of controlled clinical trials.

Constipation, cough, diarrhea, dyspnea, fatigue, upper respiratory tract infection, peripheral edema, peripheral sensory neuropathy, nausea, and insomnia were the most common adverse reactions (≥20%) in patients with AL who received the D-VCd regimen.

The recommended dose of daratumumab plus hyaluronidase human-fihj is 1800 mg of daratumumab and 30,000 units of hyaluronidase. Over approximately 3 to 5 minutes, it is subcutaneously administered into the abdomen according to the recommended schedule in combination with VCd.

The latest daratumumab plus hyaluronidase human-fihj prescribing information is available on the FDA website at www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s002lbl.pdf.

Source: US Food and Drug Administration. FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis. Published January 15, 2021. www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis#:~:text=On%20January%2015%2C%202021%2C%20the,light%20chain%20(AL)%20amyloidosis. Accessed February 26, 2021.