EC grants conditional approval to Janssen’s Darzalex to treat multiple myeloma

24 May 2016 (Last Updated May 24th, 2016 18:30)

Johnson & Johnson subsidiary Janssen-Cilag International has received conditional approval from the European Commission (EC) for its Darzalex (daratumumab).

plasma

Johnson & Johnson subsidiary Janssen-Cilag International has received conditional approval from the European Commission (EC) for its Darzalex (daratumumab).

Darzalex (daratumumab) is used for monotherapy of adult patients affected with relapsed and refractory multiple myeloma (MM).

The drug can be used on MM patients whose earlier therapy included a proteasome inhibitor (PI) and an immunomodulatory agent, and who have exhibited disease progression on the last therapy.

Daratumumab is the first CD38-directed monoclonal antibody (mAb) to be approved in Europe.

Daratumumab functions by binding to CD38, which is a signalling molecule that is highly expressed on the surface of MM cells irrespective of the stage of the disease.

Through this process, Daratumumab triggers the patient's own immune system to fight the cancer cells, thereby resulting in rapid tumour cell death through multiple immune-mediated mechanisms of action, as well as through immunomodulatory effects.

This also allows direct tumour cell death through apoptosis, that is, programmed cell death.

Universidad de Navarra Spain clinical and translational medicine director Jesus San Miguel said: "Daratumumab has shown promising efficacy results and a manageable safety profile as a single agent for heavily pre-treated and refractory myeloma patients.

"Overall survival improved significantly in these patients, whose prognosis is typically very poor, and who therefore have the greatest need for new treatments."

"Overall survival improved significantly in these patients, whose prognosis is typically very poor, and who therefore have the greatest need for new treatments."

The EC approval was based on the data collected from the Phase II MMY2002 (SIRIUS) study, the data from Phase I/II GEN501 study, as well as three additional supportive studies.

Janssen Europe, Middle East and Africa company group chairman Jane Griffiths said: "The approval of daratumumab within an accelerated timeframe is a result of working with patient-focused urgency, delivering against unmet needs with transformational science and through strong collaborations.

"We are delighted that daratumumab has been approved in Europe and will continue to study its potential across the treatment continuum in multiple myeloma and other tumour types."

In August 2012, Janssen licensed daratumumab from Danish biotechnology company Genmab and now owns exclusive rights to its development, manufacturing and commercialisation across the globe.


Image: Micrograph of a plasmacytoma, which is the histologic correlate of multiple myeloma. Photo: courtesy of Nephron.