Europe – Janssen bags new EU approval for Darzalex

Janssen’s Darzalex has been approved in Europe for the first-line treatment of patients with multiple myeloma.

In 2015, the drug became the first CD38-directed antibody to receive regulatory approval to treat relapsed or refractory forms of the disease.

Regulators have now expanded its scope to include untreated patients, when given alongside bortezomib, melphalan and prednisone (VMP), ineligible for autologous stem cell transplant (ASCT).

The decision rides on the back of data from the Phase III ALCYONE trial, which showed the Darzalex (daratumumab)-based regimen cut the risk of disease progression or death by 50 percent in this patient population.

Darzalex also significantly improved overall response rates compared to VMP alone (91 percent versus 74 percent), including more than doubling rates of stringent complete response (18 percent vs 7 percent) and boosting complete response or better (43 percent vs 24 percent)…