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Photo courtesy of Janssen
The US Food and Drug Administration (FDA) has granted accelerated approval for daratumumab (Darzalex).
The drug is now approved to treat patients with multiple myeloma (MM) who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
Daratumumab is the first monoclonal antibody approved to treat MM.
The drug works by binding to CD38 on the surface of MM cells. It triggers the patient’s own immune system to attack MM cells, resulting in cell death through multiple mechanisms of action.
Daratumumab is being developed by Janssen Biotech. The drug was previously granted breakthrough designation, orphan designation, and priority review from the FDA.
Daratumumab was approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.
As a condition of this accelerated approval, Janssen is required to conduct a multicenter, randomized trial establishing the superiority of daratumumab over standard therapy to verify and describe the clinical benefit of daratumumab. Janssen has several ongoing, multicenter, randomized trials with a primary endpoint of progression-free survival.
The recommended dose and schedule for daratumumab is 16 mg/kg once every week for 8 weeks, then once every 2 weeks for 16 weeks, then once every 4 weeks until disease progression.
The FDA said blood banks should be informed that patients are receiving daratumumab because the drug may interfere with tests such as antibody screening.
In addition, women who are pregnant should not use daratumumab, and women planning to become pregnant should use effective contraceptives during and for at least 3 months after stopping daratumumab.
Trial data
The FDA’s approval of daratumumab was based on results of 2 studies—the phase 2 MMY2002 (SIRIUS) study and the phase 1/2 GEN501 study.
The GEN501 study enrolled 102 patients with relapsed MM or relapsed MM that was refractory to 2 or more prior lines of therapy. The patients received daratumumab at a range of doses and on a number of different schedules.
The results suggested that daratumumab is most effective at a dose of 16 mg/kg. At this dose, the overall response rate was 36%.
Most adverse events in this study were grade 1 or 2, although serious events did occur.
The SIRIUS study enrolled 124 MM patients who had received 3 or more prior lines of therapy. They received daratumumab at different doses and on different schedules, but 106 of the patients received the drug at 16 mg/kg.
Twenty-nine percent of the 106 patients responded to treatment, and the median duration of response was 7 months. Thirty percent of patients experienced serious adverse events. 
Photo courtesy of Janssen
The US Food and Drug Administration (FDA) has granted accelerated approval for daratumumab (Darzalex).
The drug is now approved to treat patients with multiple myeloma (MM) who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
Daratumumab is the first monoclonal antibody approved to treat MM.
The drug works by binding to CD38 on the surface of MM cells. It triggers the patient’s own immune system to attack MM cells, resulting in cell death through multiple mechanisms of action.
Daratumumab is being developed by Janssen Biotech. The drug was previously granted breakthrough designation, orphan designation, and priority review from the FDA.
Daratumumab was approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.
As a condition of this accelerated approval, Janssen is required to conduct a multicenter, randomized trial establishing the superiority of daratumumab over standard therapy to verify and describe the clinical benefit of daratumumab. Janssen has several ongoing, multicenter, randomized trials with a primary endpoint of progression-free survival.
The recommended dose and schedule for daratumumab is 16 mg/kg once every week for 8 weeks, then once every 2 weeks for 16 weeks, then once every 4 weeks until disease progression.
The FDA said blood banks should be informed that patients are receiving daratumumab because the drug may interfere with tests such as antibody screening.
In addition, women who are pregnant should not use daratumumab, and women planning to become pregnant should use effective contraceptives during and for at least 3 months after stopping daratumumab.
Trial data
The FDA’s approval of daratumumab was based on results of 2 studies—the phase 2 MMY2002 (SIRIUS) study and the phase 1/2 GEN501 study.
The GEN501 study enrolled 102 patients with relapsed MM or relapsed MM that was refractory to 2 or more prior lines of therapy. The patients received daratumumab at a range of doses and on a number of different schedules.
The results suggested that daratumumab is most effective at a dose of 16 mg/kg. At this dose, the overall response rate was 36%.
Most adverse events in this study were grade 1 or 2, although serious events did occur.
The SIRIUS study enrolled 124 MM patients who had received 3 or more prior lines of therapy. They received daratumumab at different doses and on different schedules, but 106 of the patients received the drug at 16 mg/kg.
Twenty-nine percent of the 106 patients responded to treatment, and the median duration of response was 7 months. Thirty percent of patients experienced serious adverse events.
Photo courtesy of Janssen
The US Food and Drug Administration (FDA) has granted accelerated approval for daratumumab (Darzalex).
The drug is now approved to treat patients with multiple myeloma (MM) who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
Daratumumab is the first monoclonal antibody approved to treat MM.
The drug works by binding to CD38 on the surface of MM cells. It triggers the patient’s own immune system to attack MM cells, resulting in cell death through multiple mechanisms of action.
Daratumumab is being developed by Janssen Biotech. The drug was previously granted breakthrough designation, orphan designation, and priority review from the FDA.
Daratumumab was approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.
As a condition of this accelerated approval, Janssen is required to conduct a multicenter, randomized trial establishing the superiority of daratumumab over standard therapy to verify and describe the clinical benefit of daratumumab. Janssen has several ongoing, multicenter, randomized trials with a primary endpoint of progression-free survival.
The recommended dose and schedule for daratumumab is 16 mg/kg once every week for 8 weeks, then once every 2 weeks for 16 weeks, then once every 4 weeks until disease progression.
The FDA said blood banks should be informed that patients are receiving daratumumab because the drug may interfere with tests such as antibody screening.
In addition, women who are pregnant should not use daratumumab, and women planning to become pregnant should use effective contraceptives during and for at least 3 months after stopping daratumumab.
Trial data
The FDA’s approval of daratumumab was based on results of 2 studies—the phase 2 MMY2002 (SIRIUS) study and the phase 1/2 GEN501 study.
The GEN501 study enrolled 102 patients with relapsed MM or relapsed MM that was refractory to 2 or more prior lines of therapy. The patients received daratumumab at a range of doses and on a number of different schedules.
The results suggested that daratumumab is most effective at a dose of 16 mg/kg. At this dose, the overall response rate was 36%.
Most adverse events in this study were grade 1 or 2, although serious events did occur.
The SIRIUS study enrolled 124 MM patients who had received 3 or more prior lines of therapy. They received daratumumab at different doses and on different schedules, but 106 of the patients received the drug at 16 mg/kg.
Twenty-nine percent of the 106 patients responded to treatment, and the median duration of response was 7 months. Thirty percent of patients experienced serious adverse events.