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news.Janssen-Cilag International has submitted an application to the European Medicines Agency (EMA) to expand the existing marketing authorization for its immunotherapy Darzalex (daratumumab) to include combination with standard of care regimens.
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The company is seeking approval of Darzalex, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, to treat adult patients with relapsed multiple myeloma (MM) who have received at least one prior line of therapy.
The Type II variation application submission is based on data from two Phase 3 studies demonstarting daratumumab in combination with standard of care regimens resulted in a reduction in the risk of disease progression or death.
Janssen Europe, Middle East and Africa company group chairman Jane Griffiths said: “Despite remarkable advances over recent years, multiple myeloma remains an incurable illness. We are therefore excited to take an important step forward in further realising the potential of daratumumab, and its possible benefit as a backbone therapy in multiple myeloma treatment.
“We look forward to working closely with the EMA throughout the review process and remain committed to exploring the full clinical benefit of this compound for patients who are awaiting new options.”
The European Commission has already approved Darzalex for monotherapy treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior lines of therapy.
Daratumumab targets CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.
It induces rapid tumour cell death through apoptosis and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
Daratumumab has also showed immunomodulatory effects that contribute to tumour cell death through a decrease in immune suppressive cells including T-regs, B-regs and myeloid-derived suppressor cells.
Image: Darzalex is a monoclonal antibody that is designed to help the body's immune system fight cancer cells. Photo: courtesy of Johnson & Johnson Services, Inc.