Lisocabtagene maraleucel (liso-cel) is an investigational, autologous chimeric antigen receptor (CAR) T-cell therapy, a novel type of immunotherapy in which a patient’s own immune cells are genetically re-programmed to target and attack cancer cells. It is proposed to treat adults with relapsed or refractory large B-cell lymphoma after at least 2 prior therapies.
Horizon Scanning
It is a challenge for health plans and clinicians to know what emerging technologies are in the preapproval phase and what their clinical, financial, and risk impacts might be. This is where we come in.The Hayes Horizon Scanning Solution identifies innovative and potentially disruptive health technologies that are in various stages of the regulatory approval process. Our Research Analysts continually investigate new technologies that are on the horizon or in the early stages of clinical investigation, as well as the testing of existing technologies that may be seeking approval for new clinical applications. Hayes Horizon Scanning helps you track emerging technologies before you need to make decisions. Accessed through the Hayes Knowledge Center, Hayes Horizon Scanning addresses the following fundamental questions to help our clients forecast emerging technologies:
- Is this emerging technology new or replacing an existing technology?
- Where is this technology in the FDA regulatory process?
- When will this technology be commercially available in the market?
- What is the projected use, cost, and financial impact of this technology?
Sutimlimab for Cold Agglutinin Disease
Sutimlimab is an intravenous monoclonal antibody targeting complement component 1s (C1s) for the treatment of cold agglutinin disease.
Narsoplimab for Stem Cell Transplant-Associated Thrombotic Microangiopathy
Narsoplimab is an investigational, intravenous monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Aducanumab for Alzheimer Disease
Aducanumab is an investigational human monoclonal anti-amyloid beta antibody in development for the treatment of Alzheimer disease.
Mavacamten for Hypertropic Cardiomyopathy
Mavacamten is an investigational oral myosin inhibitor that targets the underlying molecular mechanisms of hypertrophic cardiomyopathy (HCM). It is proposed for the treatment of patients with obstructive HCM.
Vosoritide for Achondroplasia
Vosoritide is a longer-acting C-type natriuretic peptide (CNP) analog that modulates activity of the fibroblast growth factor receptor 3 (FGFR3) by inhibiting a signaling pathway that mediates its effects, thereby stimulating endochondrial growth, resulting in enhanced growth velocity. It is proposed for the treatment of achondroplasia.
Idecabtagene Vicleucel for Multiple Myeloma
Idecabtagene vicleucel is an investigational chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA). It is proposed for the treatment of adults with relapsed/refractory multiple myeloma who have received at least 3 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
WiSE Cardiac Resynchronization Therapy System
The WiSE CRT system is a wireless left ventricular pacing system that works with an implanted right ventricular pacemaker and/or defibrillator for patients in whom cardiac resynchronization therapy (CRT) is indicated.
Remestemcel-L for Acute Graft-Versus-Host Disease
Remestemcel-L is an investigational allogeneic liquid cell suspension of ex-vivo cultured adult human mesenchymal stem cells derived from healthy donor bone marrow proposed for the treatment of pediatric patients with acute graft-versus-host-disease (aGVHD) refractory to standard first-line steroid therapy.
Evinacumab for Homozygous Familial Hypercholesterolemia
Evinacumab is an intravenously administered monoclonal antibody proposed for use as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH).