Janssen Announces FDA Approval of Darzalex as First-Line Therapy for Transplant-Ineligible Multiple Myeloma Patients

Today, Janssen, a company under the Johnson & Johnson group, announced that the U.S. FDA has approved Darzalex (daratumumab), jointly developed by Janssen and Genmab, in combination with lenalidomide and dexamethasone, for the treatment of newly diagnosed multiple myeloma (MM) patients who are ineligible for autologous stem cell transplantation (ASCT). Compared to the standard regimen of lenalidomide and dexamethasone (Rd), this combination therapy reduces the risk of disease progression or death by 44%.

Multiple myeloma is a malignant hematologic cancer caused by the malignant transformation of plasma cells in the bone marrow. It is estimated that in 2019, more than 30,000 people in the United States will be diagnosed with this disease, and approximately 13,000 will die from it. Current main treatment regimens for multiple myeloma include chemotherapy, immunomodulatory drugs (IMiDs, such as lenalidomide), and/or proteasome inhibitors (PIs, such as bortezomib), with or without stem cell transplantation.

Darzalex specifically recognizes CD38, which is highly expressed on malignant plasma cells in multiple myeloma, with high affinity, thereby inducing tumor cell death through various immune-mediated mechanisms. Since its launch in 2015, this new drug has received multiple FDA approvals to expand its indications for the treatment of patients with multiple myeloma. This newly approved combination therapy is the second first-line multiple myeloma regimen containing Darzalex approved by the FDA, providing patients with additional treatment options.

▲Mechanism of Action of Darzalex (Image source: Darzalex official website)

This approval is based on the MAIA trial, an open-label, randomized Phase 3 clinical study. A total of 737 newly diagnosed patients received either Darzalex plus Rd (lenalidomide and dexamethasone) or Rd alone. The trial results demonstrated that adding Darzalex to the Rd regimen further improved patient responses. Compared with Rd alone, the Darzalex combination reduced the risk of disease progression or death by 44%. Furthermore, the complete response rate (48% vs. 25%), very good partial response rate (79% vs. 53%), and overall response rate (93% vs. 81%) were all significantly higher in the Darzalex combination group. The proportion of patients achieving minimal residual disease (MRD) negativity was three times higher in the Darzalex combination therapy group than in the control group (24% vs. 7%).

“Optimizing response to first-line therapy is critical for patients with multiple myeloma,” said Mr. Paul Giusti, President and Chief Executive Officer of the Multiple Myeloma Research Foundation. “The recent approval of Darzalex represents a welcome advancement for the multiple myeloma community. We are deeply grateful to Janssen for its research, as well as to the patients and healthcare professionals who participated in this study.”

References:

[1] Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible. Retrieved June 27, 2019, from https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-darzalex-daratumumab-in-combination-with-lenalidomide-and-dexamethasone-for-newly-diagnosed-patients-with-multiple-myeloma-who-are-transplant-ineligible-300876400.html

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