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Home Industry News Janssen files for EU regulatory approval of multiple myeloma drug

Janssen files for EU regulatory approval of multiple myeloma drug

15th September 2015

Janssen has filed for European regulatory approval of daratumumab, its new investigational, human anti-CD38 monoclonal antibody for the treatment multiple myeloma.

The company has submitted a new marketing authorisation application to the European Medicines Agency seeking approval of the therapy for patients with relapsed and refractory multiple myeloma.

Data from the phase II MMY2002 monotherapy study and the phase I/II GEN501 monotherapy trial, as well as the findings of three supportive studies, has demonstrate the safety and efficacy of the therapy.

Daratumumab works by binding to CD38, a signalling molecule found on the surface of multiple myeloma cells. In doing so, it triggers the patient's own immune system to attack the cancer cells,

Jane Griffiths, company group chairman for Janssen in Europe, the Middle East and Africa, said: "Through our continued commitment to research into new therapies and innovative mechanisms, we are encouraged to see the depth of therapeutic response with daratumumab."

This comes after the firm completed a rolling submission of a biologic licence application for daratumumab to the US Food and Drug Administration in July 2015.ADNFCR-8000103-ID-801800468-ADNFCR

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