Janssen Submits sBLA for Daratumumab Combo to Treat Multiple Myeloma

Janssen Pharmaceutical Companies submitted a supplemental biologics license application for daratumumab in combination with carfilzomib and dexamethasone to treat patients with relapsed/refractory multiple myeloma.

Janssen Pharmaceutical Companies, of Johnson & Johnson, submitted a supplemental biologics license application (sBLA) to the FDA looking for approval of daratumumab (Darzalex) in combination with carfilzomib (Kyprolis) and dexamethasone, also known as DKd, according to a Janssen news release.

"While we continue to make important strides in the treatment of multiple myeloma, unfortunately most patients will relapse at some point, so it is important that physicians have multiple treatment options and regimens for patients," Craig Tendler, MD, vice president of late development and global medical affairs at Janssen Research & Development, LLC, said in a news release.

The sBLA is supported by data from the randomized, open-label phase III CANDOR study, designed to compared DKd with carfilzomib and dexamethasone (Kd) in 466 patients with relapsed or refractory multiple myeloma. All patients had already received 1 to 3 lines of therapy prior to enrolling in the study. 

Results of the study were initially presented at the 2019 American Society of Hematology (ASH) Annual Meeting.

The primary endpoint of the study was progression free survival (PFS), with secondary endpoints including overall response rate, minimal residual disease, and overall survival. All patients enrolled in the study were treated until disease progression.

"The results from the CANDOR study support the potential benefit of this Darzalex-based combination regimen for patients with multiple myeloma who have relapsed from prior treatment," continued Tendler.

Daratumumab was previously approved by the FDA on a number of occasions, including most recently in September 2019 in combination with bortezomib, thalidomide, and dexamethasone for newly diagnosed patients eligible for autologous stem cell transplant. The monoclonal antibody was the first of its kind to be approved worldwide and is the only CD38-directed antibody approved to treat multiple myeloma.

According to the news release, over 32,000 new cases of multiple myeloma will be diagnosed in 2020, with over 12,000 deaths are expected to occur. One in 132 people are at risk of multiple myeloma in their lifetime.

Multiple myeloma occurs when normal plasma cells become cancerous and grow out of control, interrupting important functions of the immune system. The plasma cells rapidly spread, replacing normal cells with tumors in the bone marrow.


Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma [news release]. Raritan, New Jersey. Published February 10, 2020. https://www.janssen.com/janssen-announces-submission-us-fda-new-darzalexr-daratumumab-based-combination-regimen-patients. Accessed February 11, 2020.