FDA approves Janssen's Darzalex Faspro as first treatment for AL amyloidosis

Late Friday, Janssen announced that the US Food and Drug Administration has granted accelerated approval for Darzalex Faspro (the subcutaneous formulation of daratumumab), in combination with bortezomib, cyclophosphamide and dexamethasone (VCd or CyBorD for short), for the treatment of newly-diagnosed light chain (AL) amyloidosis.

This represents the first and only FDA-approved treatment option for patients with the rare and often fatal blood cell disorder that causes gradual damage to multiple organs such as the heart, kidneys and liver, said Janssen, the Pharmaceutical arm of US healthcare giant Johnson & Johnson (NYSE: JNJ).

This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Darzalex Fasbro is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.