An oral farnesoid X receptor agonist for the treatment of primary biliary cirrhosis.
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.
Rovalpituzumab Tesirine (Rova-T; SC16LD6.5) for SCLC
An intravenous antibody-drug conjugate targeting delta-like protein 3 (DLL3) for third-line treatment of small cell lung cancer.
CyPass Micro-Stent
A supraciliary microstent proposed to reduce intraocular pressure in patients with mild-to-moderate glaucoma undergoing cataract surgery.
Probuphine (Buprenorphine Extended-Release Subcutaneous Implant)
A buprenorphine subdermal implant for maintenance treatment of opioid dependence in patients stabilized on a transmucosal buprenorphine-containing product at doses of 8 milligrams per day or less.
Epclusa (Sofosbuvir and Velpatasvir) for Chronic HCV Infection
Epclusa is the first FDA-approved pangenotypic regimen for the treatment of chronic hepatitis C virus infection. The fixed-dose combination pill contains sofosbuvir 400 mg and velpatasvir 100 mg. Sofosbuvir is sold separately under the brand name Sovaldi. Velpatasvir is a new HCV NS5A inhibitor that is active across all 6 HCV genotypes; it is not sold separately.
Organ Care System (OCS) Heart
Health problem: Heart transplantation
Technology description: An ex vivo heart perfusion system for portable normothermic perfusion of donor hearts for transplantation.
Best available evidence: Single published phase II/III trial.
Regulatory status: Under FDA review.
Last updated…
Durvalumab for Non-Small Cell Lung Cancer
An investigational checkpoint inhibitor proposed as a third-line treatment for advanced non-small cell lung cancer in patients whose disease expresses programmed death-ligand 1 (PD-L1).
Darzalex (Daratumumab)
A monoclonal antibody to treat multiple myeloma in patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulator, or who are double refractory to these agents.
Venclexta (Venetoclax)
An oral B-cell lymphoma-2 inhibitor initially proposed for single-agent use to treat relapsed or refractory chronic lymphocytic leukemia in patients harboring the 17p deletion.
Zepatier (Elbasvir and Grazoprevir) for Chronic Hepatitis C Infection
A single-pill grazoprevir/elbasvir regimen for chronic HCV genotype 1, 4, or 6 infection.