Janssen’s daratumumab accepted for accelerated CHMP assessment

Janssen has announced that its multiple myeloma therapy daratumumab has been accepted for accelerated regulatory review by Europe's Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has accepted the company's request for an accelerated assessment of the drug as a single agent for the treatment of patients with relapsed and refractory multiple myeloma.

Daratumumab is an investigational anti-CD38 monoclonal antibody that helps to trigger the immune system to attack cancer cells, resulting in rapid tumour cell death through multiple immune-mediated and other mechanisms of action.

The compound was previously granted orphan drug status by the European Medicines Agency for the treatment of plasma cell myeloma.

Jane Griffiths, company group chairman for Janssen in Europe, the Middle East and Africa, said: "We continue to work closely with European health authorities to make daratumumab available to these patients as soon as possible."

Findings from the phase II MMY2002 monotherapy study and the phase I/II GEN501 monotherapy trial, as well as results from three supportive studies, have demonstrated the safety and efficacy of the therapy.