Johnson and Johnson Gets CDSCO Panel Nod For Additional Indication of Daratumumab to Treat Light chain AL amyloidosis

Amyloidosis is a disorder of protein misfolding and metabolism in which insoluble fibrils are deposited in various tissues, causing organ dysfunction and eventually death.

Primary or light chain (AL) amyloidosis, the most common type of systemic amyloidosis, occurs when the free light chains normally associated with immunoglobulins are produced in excess by clonal or frankly malignant plasma cells. Although AL amyloidosis is not considered a cancer, it shares some similar characteristics and treatments with multiple myeloma.

Daratumumab is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of multiple myeloma and light chain amyloidosis. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found in some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells.

Daratumumab binds to CD38, causing cells to apoptosis via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, inhibition of mitochondrial transfer, or antibody-dependent cellular phagocytosis.

The committee observed that the treatment of Light chain (AL) amyloidosis comes under the orphan drug category. Furthermore, the expert panel highlighted that the applied indication for the treatment of Light Chain (AL) Amyloidosis is approved in the US, EU, Canada, Brazil, Switzerland, the UK, and China.