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Janssen's Darzalex combo approved by FDA in transplant-ineligible multiple myeloma patients

Published on 28/06/19 at 11:54am

Janssen’s Darzalex (daratumumab) has secured FDA approval in combination with lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma in patients who are not eligible for autologous stem cell transplant (ASCT), the company has confirmed.

The approval, which was awarded through the US regulator’s Real-Time Oncology Review pilot programme, was based on Phase 3 data which demonstrated that, at a median follow-up of 28 months after initial treatment, the combo “significantly reduced” the risk of disease progression or death by 44% compared to lenalidomide and dexamethasone alone.

In addition, the combo improved rates of complete response, scoring 48% compared to 25% with lenalidomide and dexamethasone alone, and overall response, scoring 93% versus 81%.

 “For patients with multiple myeloma, optimising response to frontline treatment is critical,” said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation. “This latest indication for Darzalex is a promising development for the myeloma community, and we are grateful to Janssen, our long-standing partner in myeloma research, as well as the patients with myeloma and healthcare providers involved in this study.”

Dr Craig Tendler, Vice President, Clinical Development and Global Medical Affairs, Oncology, at Janssen Research & Development, added: "Today’s approval of Darzalex underscores the significant clinical benefit of this CD38 monoclonal antibody and our efforts to advance treatment paradigms to change the course of the disease. Importantly, this milestone also highlights the efficiency of the FDA's Real-Time Oncology Review process, ensuring that proven treatment regimens, such as Darzalex plus lenalidomide and dexamethasone, are made available to patients as soon as possible."

Matt Fellows

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