Janssen Announces European Commission Approval of Darzalex

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has granted marketing authorization for Darzalex (daratumumab) for use as frontline (initial) therapy. The approval is for the use of daratumumab in combination with bortezomib, melphalan and prednisone (VMP), for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval is based on results from the randomized, open-label, multicenter Phase 3 ALCYONE (MMY3007) study, published in the New England Journal of Medicine earlier this year. Daratumumab in combination with VMP reduced the risk of disease progression or death by 50 percent, compared to treatment with VMP alone (Hazard Ratio [HR] = 0.50; 95 percent CI [0.38-0.65], p<0.001). The median progression free survival (PFS) for daratumumab-VMP had not yet been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone.

“Today’s approval is extremely important for multiple myeloma patients, as providing a frontline treatment option that demonstrate a deep and durable response often provides the best chance at lasting remission. 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,” said Dr Torben Plesner, MD, the first investigator to administer daratumumab in human trials and Professor, Head of the Department of Hematology at Vejle Hospital, Denmark. “I am proud that patients across Europe now have the option to use a monoclonal antibody as an initial therapy.” “We are incredibly grateful to the patients and physicians who participated in the clinical program for making this approval possible,” said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Hematology Therapeutic Area Lead, Janssen. “Our mission has been to ensure daratumumab reaches as many eligible patients as possible and to prolong and improve their quality of life. This is a significant step forward.”

The most common (≥10 percent) Grade 3/4 treatment emergent adverse events (TEAEs) (daratumumab-VMP vs. VMP) were neutropenia (40 percent vs. 39 percent), thrombocytopenia (34 percent vs. 38 percent), anemia (16 percent vs. 20 percent) and pneumonia (11 percent vs. 4 percent). One patient in each arm discontinued treatment due to pneumonia and 0.9 percent of patients discontinued daratumumab due to an infection. Twenty-eight percent of patients experienced infusion-related reactions (IRRs) due to daratumumab, and most IRRs occurred during the first infusion.1 In the daratumumab-VMP arm, 42 percent of patients experienced a serious adverse event (SAE), compared to 33 percent in the VMP arm. The most common (≥2 percent) SAE (daratumumab-VMP vs. VMP) was pneumonia (10 percent vs. 3 percent). Additional information about this study can be found at www.ClinicalTrials.gov (NCT02195479).

In Europe, daratumumab is also indicated for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy. – Medical Buyer Bureau