Janssen bags new EU approval for Darzalex

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).

The approval "is extremely important for multiple myeloma patients, as providing a frontline treatment option that demonstrates a deep and durable response often provides the best chance at lasting remission," said Dr Torben Plesner, the first investigator to administer daratumumab in human trials and Professor, head of the Department of Hematology at Vejle Hospital, Denmark.

"It’s all the more remarkable considering it has only been ten years since the first dose of daratumumab was administered in the earliest human studies".

The Darzalex/VMP combination was approved by US regulators have in May.

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