FDA approves label extension for Darzalex-Rd in multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced FDA approval of Darzalex (daratumumab) 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). The approval is based on results from the Phase III MAIA (MMY3008) clinical study, which showed that Darzalex-Rd significantly reduced the risk of disease progression or death by 44 percent compared to treatment with Rd alone. The application received approval through the U.S. FDA's Real-Time Oncology Review (RTOR) pilot program.

Data from the Phase III MAIA study were recently published in The New England Journal of Medicine and previously presented at the 2018 American Society of Hematology (ASH) Annual Meeting. At a median follow-up of 28 months, results showed Darzalex in combination with Rd significantly reduced the risk of disease progression or death by 44 percent in patients with newly diagnosed multiple myeloma who are transplant ineligible, compared to treatment with Rd alone (Hazard Ratio [HR] = 0.56; 95 percent confidence interval [CI]: 0.43-0.73; p<0.0001). The median progression-free survival (PFS) for Darzalex-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone. The addition of Darzalex resulted in deeper responses compared to Rd alone, including increased rates of complete response (CR) or better (48 percent vs. 25 percent), very good partial response (VGPR) or better (79 percent vs. 53 percent) and overall response (93 percent vs. 81 percent).1 Darzalex-Rd induced a more than 3-fold higher rate of minimal residual disease (MRD) negativity compared to Rd alone (24 percent vs. 7 percent).