Janssen filed a supplemental Biologics License Application (sBLA) with the FDA for the approval of subcutaneous formulation of Darzalex Faspro
Johnson & Johnson (J&J) pharmaceutical business Janssen has applied with the US Food and Drug Administration (FDA) for the approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat light chain (AL) amyloidosis.
The company has filed a supplemental Biologics License Application (sBLA) with the FDA for the approval of subcutaneous formulation of Darzalex Faspro to treat patients with AL amyloidosis, a rare, potentially mortal disease with no approved therapies.
The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) programme, which facilitates the data review for certain applications before the formal submission of the complete application, said the company.
Also, the submission is being reviewed by the FDA Oncology Center of Excellence, under its Project Orbis initiative, which provides a basis for parallel submission and review of oncology medicines among global regulatory agencies.
Janssen research and development oncology clinical development and global medical affairs vice president Craig Tendler said: “We are excited about the potential of helping patients with AL amyloidosis who currently have no FDA-approved therapies for the treatment of their disease.
“The results from the Phase 3 ANDROMEDA study also provide preliminary evidence of Darzalex Faspro’s potential to modify the organ damage that is a hallmark of this serious disease with high unmet needs and we look forward to collaborating with the agency in the review of the application.”
Janssen filed sBLA for Darzalex Faspro based on Phase 3 ANDROMEDA trial results
Janssen said that its sBLA for Darzalex Faspro is based on positive results from the Phase 3 ANDROMEDA clinical trial, which evaluated Darzalex Faspro in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) versus VCd alone.
The clinical trial has enrolled 388 patients, newly diagnosed with AL amyloidosis, with a measurable hematologic disease, and with one or more organs affected.
The study has reached the primary endpoint of overall complete hematologic response rate by intent-to-treat (ITT). Major organ deterioration progression-free survival, event-free survival, organ response rate, overall survival, and time to hematologic response, include secondary endpoints of the study.
AL amyloidosis is a life-threatening disorder characterised by the accumulation of amyloid deposits in vital organs, when plasma cells in the bone marrow produce abnormal light chains, causing organ deterioration.
The disease can affect different organs in different people. However, heart, kidneys, liver, spleen, GI tract and nervous system are the most frequently affected organs. Currently, no FDA approved therapies are available for the treatment of the disease.