SMC accepts first licensed treatment for newly diagnosed AL amyloidosis

pharmafile | August 9, 2022 | News story | Manufacturing and Production  

The SMC has accepted the first licensed treatment for adults with newly diagnosed systemic light chain (AL) amyloidosis.

Darzalex® (daratumumab) in combination with bortezomib, cyclophosphamide and dexamethasone (DBCd), has demonstrated a deep and durable response, that reduces organ deterioration, and improves quality of life, compared to bortezomib, cyclophosphamide, and dexamethasone (BCd) alone.

The combination, by Janssen Pharmaceutical Companies of Johnson & Johnson, was generally well-tolerated by patients. Daratumumab is a human monoclonal antibody targeting the CD38 molecule, which is uniformly expressed on clonal plasma cells.

Amanda Cunnington, Director of Patient Access, Janssen-Cilag Limited commented:

“This is an important milestone for patients with newly diagnosed systemic AL amyloidosis who need effective and well-tolerated treatments. DBCd is the first licensed treatment for this group of patients and will play an important role in helping to reduce symptom burden and improve quality of life for those living with this disease.”

AL amyloidosis is a rare and incurable bone marrow disorder, which carries debilitating symptoms. These include life-threatening organ damage, which can cause heart failure and liver failure. Heart failure may cause oedema or swelling caused due to excess fluid accumulation in the body tissues, arrhythmia. Other symptoms of AL amyloidosis include easy bruising, feeling lightheaded or fainting, particularly after standing or sitting up, carpal tunnel syndrome, and nausea.

AL amyloidosis is caused by an abnormality in certain cells found in the bone marrow, called plasma cells. In AL amyloidosis, the abnormal plasma cells produce abnormal forms of light chain proteins, which enter the bloodstream, and can form amyloid deposits.

Cunnington continued: “The SMC acceptance provides further recognition for daratumumab and we are proud that newly diagnosed systemic AL amyloidosis patients are able to benefit from this combination treatment.”

Before the SMC’s acceptance of DBCd, there were no licensed treatment options available for people with newly diagnosed systemic AL amyloidosis in Scotland. Further, this group of patients will be the first to access DBCd as a treatment option for newly diagnosed systemic AL amyloidosis in the UK.

Ana Ovey

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