FDA Approves New Formulation of Janssen’s Darzalex for Multiple Myeloma

The FDA has approved a new formulation of Janssen’s Darzalex (daratumumab) for multiple myeloma.

The agency approved Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation, in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.

Darzalex Faspro is a fixed-dose formulation that can be administered in approximately three to five minutes, whereas the intravenous formulation takes hours.