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Darzalex® (daratumumab) has today been granted marketing authorisation by the European Commission for use across the European Union. It is specifically indicated for use as a monotherapy (i.e. a treatment which can be given on its own) in relapsed and refractory myeloma patients who have previously been treated with:

  • a proteasome inhibitor (such as Velcade®)
  • an immunomodulatory agent (such as thalidomide or Revlimid®)

Daratumumab belongs to a group of immunotherapy treatments known as “monoclonal antibodies.” Monoclonal antibodies recognise and attach to specific proteins on the surface of myeloma cells, allowing the immune system to attack and remove them.

The decision by the European Commission means that daratumumab is safe and effective and that doctors are now able to prescribe for patients.

“Today’s decision on daratumumab is fantastic news for patients as it will help to address a major area of unmet need in people with relapsed or refractory myeloma.” said Sarper Diler, MD, PhD, President of Myeloma Patients Europe. “However, there is still a lot of work to be done to ensure that daratumumab is approved for use in health systems across Europe.”

More information about this decision can be read here

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004077/smops/Positive/human_smop_000953.jsp&mid=WC0b01ac058001d127

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