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On May 8th, Johnson & Johnson announced that Darzalex (daratumumab) new indication has received FDA approval for the combined use of bortezomib, melphalan and prednisone for first-line treatment of newly diagnosed unfit autologous stem cell transplantation (ASCT) multiple myeloma patient.

In this way, Darzalex began with the FDA approval in November 2015 as a fourth-line drug for patients with multiple myeloma, steadily and steadily, expanding indications step by step, and perfectly upgraded into clinical first-line medication.

Corresponding to this, Darzalex’s annual global sales also doubled, and by 2017 it had become a heavy product of 1.242 billion U.S. dollars. So, after the approval of the first-line medication, how much Darzalex’s global sales can reach in 2018 is worthy of attention. GlobalData had predicted that Darzalex could reach $3.7 billion in sales by 2023.

In a clinical study code-named SIRIUS, daratumumab achieved a one-year overall survival rate of 65% and achieved a 30% objective response rate in patients with dual-drug resistant multiple myeloma.

Paul Richardson, chief executive of Darzalex’s clinical program, pointed out: “Multiple myeloma is a highly complex disease that is currently incurable. Almost all patients will relapse or develop resistance after treatment.” Darzalex (daratumumab) is the world’s first marketed monoclonal antibody targeting CD38 and offers a new treatment option for multiple myeloma patients who relapse after treatment with other drugs.

Darzalex’s initial dosing regimen is once per week, the loading period lasts 2 months, then enters the maintenance treatment phase and is injected once per month. Darzalex’s first-year treatment cost was approximately $135,500. After the second year, the treatment cost was reduced to approximately $76,000 due to minimal doses.

With Darzalex being approved for the first-line therapy, Janssen needs to pay $45 million in miles to Genmab, which is part of the $1.1 billion licensing deal that Johnson & Johnson and Genmab have reached for daratumumab. Johnson and Johnson and Genmab are currently developing subcutaneous injections of daratumumab and have just started clinical trials.

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