NEW BRUNSWICK (dpa-AFX) - Janssen-Cilag International NV, a Johnson & Johnson company, announced that the CHMP of the European Medicines Agency has recommended the approval of a new indication for DARZALEX, or daratumumab, subcutaneous formulation as monotherapy for the treatment of adult patients with smouldering multiple myeloma at high-risk of developing multiple myeloma. The CHMP recommendation is supported by data from the Phase 3 AQUILA study.
Ester in't Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine, said: 'Pending European Commission approval, patients and physicians will have an option to treat high-risk smouldering multiple myeloma, with the aim to intercept this complex blood cancer before it develops into active disease and importantly, before end-organ damage occurs.'
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