Health Canada approves Darzalex + bortezomib + cyclophosphamide + dexamethasone to treat light chain amyloidosis – Janssen Biotech

Health Canada has approved daratumumab injection (Darzalex SC), a subcutaneous formulation of daratumumab (Darzalex), for use in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd; VCd) in the treatment of patients with newly diagnosed light chain amyloidosis (AL).

The regulatory decision is based on data from the phase III ANDROMEDA trial (AMY3001), which demonstrated that D-VCd resulted in a hematologic complete response (CR) rate that was almost triple that of VCd alone in this population, at 53% vs 18%, respectively (P <.0001).

“AL amyloidosis is rare and can present differently from person to person, yet many patients experience organ deterioration or failure by the time they are diagnosed. I hope this approval can lead to greater awareness of this disease and the importance of early diagnosis and treatment,” Victor Zepeda, MD, assistant professor of medicine at the University of Calgary and clinician scientist at the Arnie Charbonneau Cancer Institute, stated in a press release. “Patients with this disease have extremely limited options, and today’s approval of this subcutaneous formulation of daratumumab offers new hope for those with AL amyloidosis and their caregivers.”

Light-chain Amyloidosis : Amyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. There is currently no cure or existing approved therapies for amyloidosis though it can be treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies. It is estimated that there are approximately 3,000 to 4,000 new cases of amyloidosis diagnosed annually in the U.S..