Janssen Pharmaceutical announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking 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 sBLA, based upon data from the Phase 3 MAIA (MMY3008) clinical study, is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot program, which for certain applications allows the FDA to review data before the applicant formally submits the complete application. It aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients. Selection into the RTOR pilot program does not guarantee or influence approvability of the supplemental application.
"We are pleased to complete the latest DARZALEX submission based upon the Phase 3 MAIA study, which evaluated the efficacy and safety of this anti-CD38 monoclonal antibody as a combination regimen for newly diagnosed patients with multiple myeloma who are transplant ineligible," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Vice President, Hematologic Malignancies Disease Area Leader, Janssen Research & Development, LLC. "We look forward to closely collaborating with the Agency throughout the expedited Real-Time Oncology Review process in support of this newly diagnosed, transplant ineligible multiple myeloma patient population for whom a combination treatment regimen with DARZALEX may be useful."
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Data from the Phase 3 MAIA study were presented at the 2018 American Society of Hematology (ASH) Annual Meeting and featured in the Late-Breaking Abstract session. The study found that at a median follow-up of 28 months, DARZALEX-Rd 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).1 The median progression-free survival for DARZALEX-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone.1 The addition of DARZALEX resulted in deeper responses compared to Rd alone, including increased rates of complete response or better (48 percent vs. 25 percent).1 An improved overall response rate was also demonstrated (93 percent vs. 81 percent).
The most common Grade 3/4 treatment-emergent adverse events for DARZALEX-Rd (≥10 percent) included neutropenia (50 percent), lymphopenia (15 percent), pneumonia (14 percent) and anemia (12 percent).1 Infusion-related reactions occurred in 41 percent of patients, three percent of which were Grade 3/4. The safety profile of DARZALEX was consistent with that of previous studies.