Posted by Michael Wonder on 28 Jun 2019
Janssen announces U.S. FDA approval of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant ineligible
27 June 2019 - Combination regimen reduced the risk of disease progression or death by 44% in newly diagnosed patients who are transplant ineligible.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. 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.
The approval is based on results from the Phase 3 MAIA (MMY3008) clinical study, which showed that Darzalex-Rd significantly reduced the risk of disease progression or death by 44% compared to treatment with Rd alone. The application received approval through the U.S. FDA's real-time oncology review pilot program.
