Revlimid in the relapsed refractory setting

diagnosed myeloma who did not have the intent for immediate ASCT. This study demonstrated that the addition of Velcade to Rd in patients with newly diagnosed myeloma resulted in significantly improved PFS and overall survival (OS), and had an acceptable risk-benefit profile. For more information about Velcade, read the IMF publication Understanding VELCADE® (bortezomib) injection. For more information about VRd, read the IMF publi-cation Understanding the VRd Regimen for Newly Diagnosed Myeloma. In June 2019, the FDA approved the combination of Darzalex® (daratumumab) + Rd (DRd) for the treatment of patients with newly diagnosed myeloma who are ineligible for ASCT. Darzalex is a monoclonal antibody that targets the CD38 protein on the surface of myeloma cells. The FDA approval was based on results from the phase III MAIA clinical trial, which showed that DRd significantly reduced the risk of disease progression or death by 44% compared to treatment with Rd alone. In December 2020, at the 62nd Annual Meeting and Exposition of the American Society of Hematology (ASH) the updated analysis of the phase III MAIA clinical trial was presented after 48 months of follow-up. DRd contin-ued to demonstrate a superior PFS benefit, with deeper and more durable responses than Rd alone. No new safety concerns were observed. For more information, read the IMF publication Understanding DARZALEX® (daratumumab) and DARZALEX FASPRO™ (daratumumab + hyaluronidase-fihj).

In July 2015, the FDA approved Kyprolis® (carfilzomib), a proteasome inhibitor, in combination with Rd (KRd) for patients who have received one to three prior lines of therapy. For more information, read the IMF publication Understanding KYPROLIS® (carfilzomib) for injection. In November 2015, the FDA approved Ninlaro® (ixazomib), an oral proteasome inhibitor, in combination with Rd (IRd) for patients who have had at least one prior therapy. For more information, please read the IMF publication Understanding NINLARO® (ixazomib) capsules. Also in November 2015, the FDA approved Empliciti® (elotuzumab), a monoclonal antibody, in combination with Rd (ERd) for patients who have had from one to three prior therapies. For more information, please read the IMF publication Understanding EMPLICITI® (elotuzumab). In November 2016, the FDA approved Darzalex, in combination with Rd (DRd) for myeloma patients who have received at least one prior therapy.