Janssen-Cilag International (a Johnson & Johnson company) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of a new indication for the subcutaneous formulation of Darzalex (daratumumab) as monotherapy.
This new indication is for the treatment of adult patients with smal multiple myeloma (SMM) at high risk of progression to active myeloma.
A Phase III study comparing subcutaneous daratumumab with standard surveillance showed a 51% reduction in the risk of progression or death in treated patients.
If approved, this extension would make Darzalex the first approved therapy for this asymptomatic form of the disease, which is currently managed with active surveillance alone.
This development could mark a turning point in the management strategy for myeloma by offering a proactive treatment option before organ damage occurs, the company said.
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