Zejula is an oral poly (ADP-ribose) polymerase (PARP) inhibitor. PARP inhibitors work by disabling the compromised DNA repair mechanisms of BRCA-mutated cancer cells, leading to cell death. Ovarian cancer tumors with normal BRCA genes but another homologous recombination deficiency (HRD) that disturbs normal DNA repair are also susceptible to PARP inhibitors. Zejula is indicated …
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.
Xadago (Safinamide)
Xadago is a selective, reversible MAO-B inhibitor that also inhibits release of glutamate. MAO-B inhibitors help prevent the breakdown of dopamine in the brain. Xadago is a novel reversible MAO-B inhibitor proposed as an adjunctive therapy to prolong “on” time in patients whose primary Parkinson disease therapy is not working well.
Binimetinib for NRAS-Mutated Melanoma
Binimetinib is an investigational, oral small-molecule targeting the mitogen-activated protein kinase (MAPK) pathway. Mitogen-activated protein kinase enzyme (MEK) is a key protein kinase in the MAPK pathway, which regulates several key cellular activities, including proliferation, differentiation, migration, survival, and angiogenesis. Inappropriate activation of this pathway has been shown t…
Kisqali (Ribociclib)
Kisqali is an oral cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitor. CDK 4/6 are commonly overexpressed in breast cancer tumors, and increased CDK 4/6 activity is associated with resistance to hormone therapy. Kisqali is intended for use in combination with letrozole (brand name Femara; Novartis), an aromatase inhibitor commonly prescribed for first-line hormone therapy in women with HR+/H…
Noctiva (Low-Dose Desmopressin Nasal Spray)
Noctiva is a low-dose desmopressin nasal spray proposed to treat adults with nocturia due to nocturnal polyuria. Noctiva is a new formulation of an old drug which was first approved by the FDA in 1978 under the brand name DDAVP (Ferring Pharmaceuticals Inc.). Noctiva contains cyclopentadecanolide, an excipient that facilitates rapid absorption through the nasal mucosa and allows for use …
Cobra PzF NanoCoated Coronary Stent
The Cobra PzF stent is a first-in-class nanocoated coronary stent that is FDA-approved for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. The Cobra PzF stent utilizes a proprietary Polyzene-F nanothin polymer coating on a thin strut, open cell cobalt chromium st…
Propel and Propel Mini Bioabsorbable Steroid-Releasing Sinus Implants
Propel and Propel Mini are steroid-eluting bioabsorbable sinus stents for insertion during sinus surgery or for postoperative in-office insertion to maintain sinus patency. The implant expands to prop open the sinus after sinus surgery and gradually delivers a steroid medication directly to the sinus lining as the implant dissolves. Both Propel implants release 370 micrograms of mometaso…
Tecentriq (Atezolizumab) for Urothelial Carcinoma
An intravenous programmed death ligand 1 checkpoint inhibitor for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, and for patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Zinplava (Bezlotoxumab)
An intravenously administered, single-dose monoclonal antibody intended to reduce recurrence of Clostridium difficile infection (CDI) in adult patients receiving antibacterial drug treatment for CDI who are at high risk for recurrence.
Rubraca (Rucaparib)
An oral targeted drug proposed for monotherapy in women with germline or somatic BRCA-mutated advanced ovarian cancer who have received at least 2 prior lines of chemotherapy.