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