J&J: FDA & EMA applications for Darzalex Faspro in myeloma

(CercleFinance.com) - Johnson & Johnson announces that it has submitted applications to the FDA and EMA for a new indication for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in the United States and for the subcutaneous formulation Darzalex in the European Union.


These applications are based on data from the Phase 3 study evaluating Darzalex Faspro as monotherapy in adult patients with high-risk indolent multiple myeloma.

Indolent multiple myeloma is an early form of the disease, often untreated before progression to active myeloma.

Preliminary data from the study will be presented at the ASH meeting in December 2024.

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