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Genmab and Janssen's Darzalex combo scores FDA approval in multiple myeloma

Published on 08/05/18 at 11:01am

Genmab and Janssen have revealed that their combination of Darzalex (daratumumab) with bortezomib (Velcade), melphalan, and prednisone (VMP) has received authorisation from the FDA for the treatment of newly-diagnosed multiple myeloma in patients ineligible for autologous stem cell transplant.

The decision was based on the back of Phase 3 data which showed that the Darzalex/VMP combo reduced the risk of disease progression or death by 50% compared to VMP alone, while the median progression-free survival for the combo had not yet been reached, versus the 18.1 months for patients receiving VMP alone. Additionally, overall response rates were improved for the combo, which scored 91% compared to 74% for VMP alone, while complete response or better stood at 71% versus 24%.

“With this label expansion, Darzalex becomes the first antibody therapeutic to be approved for patients with newly diagnosed multiple myeloma,” said Dr Jan van de Winkel, Chief Executive Officer of Genmab. “This is an important step forward as it provides an additional treatment option to patients who are newly diagnosed with multiple myeloma.”

Dr Maria-Victoria Mateos, Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL in Spain and primary investigator on the ALCYONE study from which the data was drawn, commented: “A patient's best chance at lasting remission often begins with a durable response to frontline therapy, because multiple myeloma can become more difficult to treat after relapse. Combination therapy with daratumumab resulted in deep and durable responses in newly diagnosed patients with multiple myeloma who are transplant ineligible, supporting this regimen as an important new treatment option for these patients.”

Genmab entered an agreement in 2012 to hand over exclusive licensing rights for Darzalex to Janssen.

“We are grateful to the patients and physicians who participated in the clinical programme that enabled today's important approval of Darzalex combination therapy as a treatment option for newly diagnosed patients with multiple myeloma who are transplant ineligible,” said Dr Peter Lebowitz, Global Therapeutic Area Head, Oncology, Janssen Research & Development. “Darzalex has redefined how we approach the treatment of multiple myeloma, and we continue to evaluate its potential in combination with other regimens, with the aim of arresting the disease at its earliest stages.”

Matt Fellows

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