Janssen’s Darzalex Faspro Secures FDA Nod for Rare Blood Disorder

Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) has been approved by the FDA for treating a rare blood disorder called light-chain amyloidosis that leads to the deterioration of vital organs, including the heart, kidneys and liver.

The drug is used in combination with bortezomib, cyclophosphamide and dexamethasone to treat newly diagnosed adult patients who cannot receive a type of stem-cell transplant that uses their own stem cells.

The FDA has granted the drug an Accelerated Approval based on positive results from a phase 3 study.