Janssen Submits sBLA for Daratumumab Combo Therapy in Certain Patients with Multiple Myeloma


The latest sBLA is based on a phase 3 study evaluating the daratumumab combination regimen for newly-diagnosed patients with multiple myeloma who are ineligible for transplantation.

Janssen is seeking approval for daratumumab (Darzalex) in combination with lenalidomide and dexamethasone (Rd) as a treatment for patients with newly-diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT), according to a company press release.

The supplemental Biologics License Application (sBLA), which has been submitted to the FDA, is based on data from the phase 3 MAIA (MMY3008) clinical trial. The study included 737 newly-diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT age 45 to 90 years old. Patients received either daratumumab with Rd or Rd alone in 28-day cycles.

In the daratumumab plus Rd group, patients received daratumumab 16 mg/kg intravenously on a weekly basis for cycles 1 to 2, every 2 weeks for cycles 3 to 6, and every 4 weeks for cycle 7 and thereafter. Patients in both treatment groups received 25 mg of lenalidomide on days 1 to 21 of each 28-day cycle and dexamethasone at 40 mg once per week each cycle.

According to the data, daratumumab plus Rd reduced the risk of disease progression or death by 44% in patients compared with treatment with Rd alone (Hazard Ratio [HR] = 0.56; 95% confidence interval [CI]: 0.43-0.73; p<0.0001) at a median follow-up of 28 months. The median progression-free survival for daratumumab plus Rd has not yet been reached compared with 31.9 months for patients who received Rd alone. Additionally, patients who received daratumumab had deeper responses compared with Rd alone, including increase rates of complete response or better (48% versus 25%). Patients in the daratumumab plus Rd group also demonstrated an improved overall response rate (93% versus 81%), according to the study.

The safety profile of daratumumab was consistent with previous studies. Of the grade 3/4 treatment-emergent adverse effects for daratumumab plus Rd, the most commonly reported were neutropenia (50%), lymphopenia (15%), pneumonia (14%), and anemia (12%).

Daratumumab is currently approved as a monotherapy in patients with multiple myeloma who have received at least 3 lines of therapy, as well as in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for previously-treated multiple myeloma. Most recently, daratumumab received approval in combination with bortezomib, melphalan, and prednisone for newly-diagnosed multiple myeloma in patients who are ineligible for ASCT.

The latest sBLA is being reviewed by the FDA under the Real-Time Oncology Review pilot program, according to Janssen.


Janssen Submits Application to the US FDA Seeking Approval of Darzalex (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible [news release]. Janssen. https://www.janssen.com/janssen-submits-application-us-fda-seeking-approval-darzalex-daratumumab-combination-therapy. Accessed March 13, 2019.

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