Afamitresgene autoleucel is an investigational autologous engineered T-cell therapy for the treatment of HLA-A*02 positive patients with advanced synovial sarcoma expressing the MAGE-A4 antigen.
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
Atidarsagene Autotemcel (Lenmeldy; Orchard Therapeutics) for Metachromatic Leukodystrophy
Atidarsagene autotemcel (Lenmeldy; Orchard Therapeutics) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of children with presymptomatic late infantile, presymptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy (MLD).
Blarcamesine (Anavex 2-73; Anavex Life Sciences Corp.) for Alzheimer Disease
Blarcamesine (Anavex 2-73; Anavex Life Sciences Corp.) is an investigational oral small molecule sigma-1 receptor agonist for treatment of early Alzheimer disease.
AGENT Drug-Coated Balloon (Boston Scientific Corp.) for Coronary In-stent Restenosis
The AGENT Drug-Coated Balloon (Boston Scientific Corp.) is a paclitaxel-coated balloon catheter indicated for treatment of coronary in-stent restenosis (ISR). It is intended to be used after appropriate vessel preparation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 millimeters (mm) to 4.0 mm in diameter and lesions up to 26 m…
ProSense System (IceCure Medical) for Low-Risk Early-Stage Breast Cancer
The ProSense system (IceCure Medical) is a minimally-invasive, imaging-guided, cryoablation system proposed for treatment of low-risk early-stage breast cancer in patients who are not suitable candidates for surgical alternatives.
Donanemab (Eli Lilly and Co.) for Alzheimer Disease
Donanemab (Eli Lilly and Co.) is an investigational, intravenously administered amyloid beta-directed antibody proposed for the treatment of Alzheimer disease.
Nemolizumab (Galderma) for Prurigo Nodularis
Nemolizumab (Galderma) is a subcutaneously injected interleukin-31 receptor alpha antagonist under investigation for the treatment of adult patients with prurigo nodularis.
Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) for Advanced Melanoma
Lifileucel (Amtagvi; Iovance Biotherapeutics Inc.) is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Marnetegragene Autotemcel (Rocket Pharmaceuticals Inc.) for Severe Leukocyte Adhesion Deficiency-I
Marnetegragene autotemcel (Rocket Pharmaceuticals Inc.) is an investigational gene therapy administered by intravenous infusion for the treatment of severe leukocyte adhesion deficiency-I.
Human Acellular Vessel (HAV; Humacyte Inc.) for Dialysis Access
Human Acellular Vessel (HAV; Humacyte Inc.) is an investigational bioengineered vascular conduit proposed to establish arteriovenous access for hemodialysis in patients with end-stage renal disease.