EC grants conditional approval for Janssen's daratumumab

The European Commission (EC) has granted conditional approval for US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech’s single agent Darzalex (daratumumab), it has been announced.

Daratumumab for the treatment of patients with relapsed and refractory multiple myeloma (MM) is the first CD38-directed monoclonal antibody (MAb) to receive European approval and was approved under an accelerated assessment, a process reserved for medicinal products expected to be of major public health interest.

Jane Griffiths, company group chairman of Janssen Europe, Middle East and Africa, 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 tumor types.”