sBLA Submitted for Daratumumab Combo for Transplant-Eligible Patients With Multiple Myeloma


The daratumumab (Darzalex) combination therapy would be the first for use in the frontline setting for transplant-eligible patients with multiple myeloma.

Janssen is seeking approval of its multiple myeloma drug daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone (Vtd) for newly-diagnosed patients who are eligible for autologous stem cell transplant (ASCT), according to a press release.

Multiple myeloma, a type of incurable blood cancer that affects plasma cells, is estimated to affect 32,110 individuals and will cause a projected 12,960 deaths in the United States in 2019. This indication would represent the first use of daratumumab combination in the frontline setting for transplant-eligible patients with the disease.

The company submitted its supplemental Biologics License Application for this indication based on results from the phase 3 CASSIOPEIA (MMY3006) clinical trial. The study included 1085 newly-diagnosed patients with previously untreated symptomatic multiple myeloma who were eligible for high-dose chemotherapy and stem cell transplant. Janssen also previously submitted an application for the approval of daratumumab in combination with lenalidomide and dexamethasone for patients with newly-diagnosed multiple myeloma who are ineligible for ASCT.

Daratumumab is the first CD38-directed antibody approved to treat multiple myeloma. The drug works by binding to CD38 and inhibiting tumor cell growth, which causes myeloma cell death.

For the first part of the study, patients received induction treatment with Vtd alone or in combination with daratumumab high-dose therapy and ASCT, and consolidation therapy with Vtd alone or in combination with daratumumab. In the second part, which is ongoing, patients who achieved a partial response or better in part 1 will undergo a second randomization to receive maintenance treatment with daratumumab 16 mg/kg every 8 weeks or up to 2 years or observed with no further treatment.

According to Janssen, the study met its primary endpoint of the proportion of patients who achieved stringent complete response after induction and consolidation therapy. The primary endpoint of part 2 is progression-free survival.

“This submission marks an important step in the pursuit of potential treatment for newly diagnosed patients living with multiple myeloma, as Darzalex has the potential to improve clinical outcomes in combination with a standard regimen,” Yusri Elsayed, MD, MHSc, PhD, vice president of hematologic malignancies disease area leader at Janssen Research & Development, LLC, said in a statement. “We look forward to working closely with the FDA during the review of the submission with the goal of bringing a new treatment option to newly diagnosed patients who are transplant eligible.”

Daratumumab is currently being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.


Janssen Submits Application for Darzalex (daratumumab) Combination Therapy to US FDA for Newly Diagnosed Transplant Eligible Patients with Multiple Myeloma [news release]. Janssen. Accessed March 26, 2019.

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