Category: FDA

Daratumumab has just been granted approval by the FDA for the treatment of AL Amyloidosis in the United States. Today marks a major milestone and an achievement that has been years in the making.

Janssen applied for FDA approval for subcutaneous daratumumab (Darzalex Faspro) this summer for the treatment of AL Amyloidosis. It was previously approved for the treatment of multiple myeloma, and trials showed remarkable promise for its use in AL amyloidosis. The application is based on data from the phase 3 ANDROMEDA trial which demonstrated the superiority of subcutaneous daratumumab formulation plus cyclophosphamide, bortezomib, and dexamethasone (CyBorD) over CyBorD alone. Results showed that the subcutaneous daratumumab combination resulted in deeper and more rapid hematologic responses, meeting the primary end point of the trial.

“As many as 30 percent of patients with AL amyloidosis die within the first year after diagnosis, presenting an urgent need for awareness to help in the fight against this rare blood disease,” said Raymond L. Comenzo, M.D., Director, John C. Davis Myeloma and Amyloid Program, Tufts Medical Center, and ANDROMEDA study investigator. “These patients would greatly benefit from an immunotherapeutic such as an anti-CD38 monoclonal antibody with the potential to reduce and possibly stop the organ deterioration that is a characteristic of this serious disease. The results of the ANDROMEDA trial clearly support that potential and importantly create the opportunity for patients with AL amyloidosis to have at last an approved drug regimen for initial therapy.”

“This is a big step forwards for the amyloidosis community” says Isabelle Lousada, ARC CEO “The approval of daratumamab offers a much needed-treatment option for patients with AL amyloidosis”

With the first therapeutic treatment now FDA-approved for AL amyloidosis, and more research and clinical trials underway, patients have hope for their health and future. Talk to your healthcare team to discover if daratumumab is an option for you.

Thank you to Janssen and FDA for your commitment to the development of this important treatment for to amyloidosis.

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