Janssen seeks EMA’s expanded approval for DARZALEX in AL amyloidosis

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) seeking the expanded approval for DARZALEX (daratumumab) in subcutaneous (SC) formulation to include the treatment of patients having light chain (AL) amyloidosis.

Considered as a rare and potentially fatal disease, AL amyloidosis is due to the build-up of amyloid, an insoluble protein in tissues and organs, which interferes with healthy tissue and organ function.

Presently, there are no therapeutic options that have been approved by the EMA, the US Food and Drug Administration (FDA) or other regulatory authorities for the treatment of the disease.

Janssen said that the submission is based on the findings of the phase 3 ANDROMEDA study. The late-stage trial assessed the efficacy and safety of daratumumab SC in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) in comparison to bortezomib, cyclophosphamide, and dexamethasone (VCd) alone in the treatment of AL amyloidosis.

Data from the study showed a considerably higher haematologic complete response rate for patients with the addition of daratumumab in comparison to patients treated with VCd alone.

Craig Tendler – Vice President, Late Development and Global Medical Affairs, Janssen Research & Development said: “Daratumumab is an important foundational therapy in the treatment of multiple myeloma and now, on the basis of the ANDROMEDA study results, has shown that it can improve outcomes in a related plasma cell disorder, AL amyloidosis.

“We are excited about the potential for daratumumab, as part of a regimen for newly diagnosed patients with AL amyloidosis to alter the poor prognosis of their disease and reduce organ damage, which is an unfortunate life-threatening complication of this serious disease.”

Janssen submitted a supplemental biologics licence application (sBLA) in September 2020 to the US FDA seeking approval of the subcutaneous formulation of daratumumab for the treatment of AL amyloidosis.