J&J: FDA approval in multiple myeloma

(CercleFinance.com) - Johnson & Johnson announced that the FDA has approved Darzalex Faspro in combination with bortezomib, lenaalidomide and dexamethasone (D-VRd) for initial treatment and consolidation in patients with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem cell transplantation.


This approval is based on the results of a Phase III study showing that D-VRd significantly improved progression-free survival compared with the traditional VRd regimen, with a 60% reduction in the risk of progression or death.

Minimal residual disease (MRD) negativity rates were also higher with D-VRd. The new treatment thus offers greater depth of response and prolonged remissions.


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