FDA Approves Combo Regimen for New Multiple Myeloma Indication

Officials with the FDA have approved daratumumab (Darzalex, Janssen) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly-diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT), according to a press release.

The approval of the combination therapy is the sixth FDA-approved indication for daratumumab in multiple myeloma and second for newly-diagnosed patients.

Based on data from the phase 3 MAIA study, daratumumab plus Rd reduced the risk of disease progression or death by 44% in newly-diagnosed patients who are transplant ineligible. According to lead study author Saad Usmani, MD, FACP, department of hematologic oncology and blood disorders, from Levine Cancer Institute/Carolinas HealthCare System, the regimen has been submitted to the NCCN Multiple Myeloma Panel for review and consideration for potential inclusion in the NCCN Clinical Practice Guidelines

“Multiple myeloma can become more difficult to treat after relapse, so it is important that patients receive an efficacious upfront therapy with a goal of extending their first remission period,” lead study author Saad Usmani, MD, FACP, department of hematologic oncology and blood disorders, from Levine Cancer Institute/Carolinas HealthCare System, said in a statement.

According to Dr Usmani, the regimen has been submitted to the NCCN Multiple Myeloma Panel for review and consideration for potential inclusion in the NCCN Clinical Practice Guidelines

The MAIA trial included 737 newly-diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT ages 45 to 90 years old. Patients received either daratumumab plus Rd or Rd alone in 28-day cycles.

Compared with Rd alone, the combination regimen significantly reduced the risk of disease progression or death in patients. The median progression-free survival (PFS) for daratumumab plus Rd has not yet been reached, compared with 31.9 months for patients who received Rd alone, according to the study. Daratumumab demonstrated deeper responses compared with Rd alone, including increased rates of complete response or better (48% versus 25%), very good partial response or better (79% versus 53%), and overall response (93% versus 81%). Additionally, the data showed that daratumumab plus Rd induced a more than 3-fold higher rate of minimal residual disease negativity compared with Rd alone (24% versus 7%).

Daratumumab’s safety profile was consistent with that of previous studies. The most commonly reported adverse effects were infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, upper respiratory tract infection, bronchitis, pneumonia, decrease appetite, muscle spasms, peripheral sensory neuropathy, dyspnea, and cough.

“Today’s approval of Darzalex underscores the significant clinical benefit of this CD38 monoclonal antibody and our efforts to advance treatment paradigms to change the course of the disease,” Craig Tendler, MD, vice president of clinical development and global medical affairs in oncology at Janssen Research and Development, said in a statement. “Importantly, this milestone also highlights the efficiency of the FDA’s Real-Time Oncology Review process, ensuring that proven treatment regimens, such as Darzalex plus lenalidomide and dexamethasone, are made available to patients as soon as possible.”

The application was approved through the FDA’s Real-Time Oncology Review pilot program. The program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality, according to the FDA.

Reference

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 [news release]. Janssen. https://www.janssen.com/janssen-announces-us-fda-approval-darzalex-daratumumab-combination-lenalidomide-and-dexamethasone. Accessed June 27, 2019.