Retevmo (selpercatinib) is a novel oral highly selective RET inhibitor indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).
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?
Lisocabtagene Maraleucel for Large B-Cell Lymphoma
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.
Voclosporin for Lupus Nephritis
Voclosporin is an oral, investigational calcineurin inhibitor (CNI) that is similar in structure to cyclosporine. It is proposed as an addition to standard induction therapy for the treatment of active lupus nephritis in adult patients.
Enspryng (Satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder
Enspryng (satralizumab) is interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. It is administered by subcutaneous injection.
Evrysdi (Risdiplam) for Spinal Muscular Atrophy
Evrysdi (risdiplam; formerly RG7916) is an oral small molecule splicing modifier of the survival motor neuron 2 (SMN2) gene indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.
Anifrolumab for Systemic Lupus Erythematosus
Anifrolumab is an investigational fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of all type I IFNs. It is proposed for the treatment of adults with moderately to severely active systemic lupus erythematosus (SLE) who are receiving standard care.
Dexamethasone for Treatment of COVID-19
Dexamethasone is a glucocorticoid that is FDA-approved for numerous indications; it is under investigation for the treatment of COVID-19. Glucocorticoids are adrenocortical steroids that modify the body’s immune responses to diverse stimuli. Dexamethasone is indicated for treatment of allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hema…
InterAtrial Shunt Device for Heart Failure
The interatrial shunt device (IASD) is a transcatheter interatrial shunt for treatment of heart failure with preserved or borderline reduced ejection fraction. It is proposed to decrease elevated left atrial pressure in patients with heart failure and preserved or borderline reduced ejection fraction. The device is implanted within the septum separating the two atrial chamber…
Ayvakit (Avapritinib) for Gastrointestinal Stromal Tumor
Ayvakit (avapritinib) is an oral potent and selective inhibitor of activated KIT and PDGFRA mutant kinases, particularly activation loop mutations and highly resistant PDGFRA D842V mutation. It is indicated for the treatment of adults with unresectable or metastatic gastrointestinal s…
SER-109 for Fecal Microbiota Transplantation
SER-109 is an investigational microbiota-based product for fecal microbiota transplantation (FMT). It is proposed to prevent recurrent Clostridioides (formerly Clostridium) difficile infection (CDI) in adults with a history of 3 or more CDI episodes within a 9-month period. SER-109 is…