Selinexor Approved in Relapsed/Refractory Multiple Myeloma

​ Selinexor (Xpovio TM , Karyopharm Therapeutics) has received accelerated FDA approval in combination with dexamethasone for adults with relapsed or refractory multiple myeloma (RRMM) with at least four prior lines of therapy, including two or more immunomodulatory agents, two or more proteasome inhibitors, and an anti-CD38 monoclonal antibody. Supporting data came from patients in phase 2 of the STORM trial (KCP-330-012; NCT02336815). The study enrolled 122 patients with RRMM previously treate...
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New Daratumumab Combination Approved in Multiple Myeloma

The FDA has now approved daratumumab (Darzalex®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone as a first-line treatment for patients with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval was based on MAIA (NCT02252172), an open-label, active-controlled phase 3 trial that randomized 737 ASCT-ineligible patients with newly diagnosed multiple myeloma to receive either daratumumab plus lenalidomide/dexamethasone or lenalidomide...
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IPH4102: Potential Treatment for Cutaneous T-Cell Lymphoma

Researchers report that IPH4102, a first-in-class monoclonal antibody that targets killer cell immunoglobulin-like receptor 3DL2 (KIR3DL2), shows promising activity in relapsed or refractory cutaneous T-cell lymphoma (CTCL), a rare cancer that affects the skin. A cell surface protein, KIR3DL2 is expressed particularly strongly in patients with a form of CTCL called Sézary syndrome, which is an aggressive blood cancer. This international, first-in-human, open-label phase 1 clinical trial (NCT0259...
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Ruxolitinib for Steroid-Refractory Acute GVHD: An Interview With Corey S. Cutler, MD, MPH, FRCPC

Recently, the FDA approved ruxolitinib (Jakafi®, Incyte Corporation), a JAK1/JAK2 inhibitor, for the treatment of steroid-refractory acute graft-versus-host disease (GVHD). A potentially life-threatening condition, GVHD is a complication of allogeneic hematopoietic stem cell transplantation (HSCT), a treatment for hematologic malignancies that is administered following high-intensity chemotherapy or radiation. In this interview with i3 Health, Corey S. Cutler, MD, MPH, FRCPC, Medical Director of...
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Polatuzumab Vedotin Approved in Relapsed/Refractory DLBCL

The FDA has now granted accelerated approval to polatuzumab vedotin (Polivy®, Genentech, Inc.) in combination with bendamustine and a rituximab product for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, following two or more prior lines of therapy. Estimates of five-year survival for DLBCL have been reported at 62.0% in the United States and 55.4% in Europe. Over 50% of patients with advanced-stage, previously untreated DLBCL experience complet...
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