Janssen receives EU approval for multiple myeloma therapy Darzalex

Janssen has announced that its new multiple myeloma therapy Darzalex has been granted European regulatory approval.

The European Commission has granted conditional approval to Darzalex as a monotherapy for adult patients with relapsed and refractory multiple myeloma who have been previously treated with a proteasome inhibitor and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.

Darzalex was approved through an accelerated assessment process, which is reserved for medicinal products expected to be of major public health interest, particularly in terms of therapeutic innovation.

This approval was based on positive data from clinical studies, which showed that the drug was able to help stabilise the disease, while being associated with a strong overall response rate.

Jane Griffiths, company group chairman at Janssen in Europe, the Middle East and Africa, said: "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."