FDA approves new use for J&J’s Darzalex Faspro

31 July 2024

The US Food and Drug Administration (FDA) has approved a new indication for Darzalex Faspro, (daratumumab and hyaluronidase-fih) from US healthcare giant Johnson & Johnson (NYSE: JNJ).

Darzalex Faspro is now authorized in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

This approval is supported by data from the Phase III PERSEUS study evaluating Darzalex Faspro in a regimen that included D-VRd induction and consolidation therapy compared to bortezomib, lenalidomide and dexamethasone (VRd) during induction and consolidation in patients with NDMM eligible for ASCT. Following consolidation, patients received an investigational treatment regimen for maintenance that included Darzalex Faspro in combination with lenalidomide or lenalidomide alone. Darzalex generated second quarter 2024 sales of $2.88 billion.

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