NEW BRUNSWICK (dpa-AFX) - Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission has approved 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.
Separately, Janssen-Cilag announced that the European Commission has approved an indication extension of IMBRUVICA or ibrutinib in frontline mantle cell lymphoma. The approval is for ibrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone alternating with R-DHAP without ibrutinib, followed by ibrutinib monotherapy, for the treatment of adult patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant.
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