Prognosis is a horizon scanning service that monitors emerging health technologies as they go through clinical trial development and the regulatory approval process.
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Rydapt is a twice daily oral FLT3 inhibitor for the treatment of newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Rydapt is also FDA approved for treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia.
Apalumatide is an investigational oral androgen receptor inhibitor currently under FDA review for use in combination with androgen deprivation therapy for the treatment of nonmetastatic castration-resistant prostate cancer.
Voretigene neparvovec is an adenovirus-associated viral vector serotype 2 gene therapy containing the human RPE65 gene for treatment of patients with vision loss due to RPE65-mediated inherited retinal disease. Gene therapy utilizes a viral vector to carry the desired genetic information to target cells; vectors that are successfully transduced into target cells utilize the cell to express the proteins of interest. The goal of gene therapy is to provide a sustained therapeutic benefit via continual expression of the proteins that modulate the pathogenesis of the relevant disease. Voretigene is injected subretinally under general anesthesia.
The Sentinel Cerebral Protection System (CPS) is a dual filter cerebral embolic protection device indicated for use during transcatheter aortic valve replacement (TAVR). The device contains 2 independent filters within a single delivery catheter that is delivered via the right radial artery or brachial artery. The larger proximal filter is deployed in the brachiocephalic trunk, and the smaller distal filter is deployed in the left common carotid artery before TAVR. The Sentinel CPS filters and collects debris released during the TAVR procedure.
OTX-TP is an eye insert that delivers travoprost to the ocular surface for up to 90 days. It is proposed as an alternative to daily eye drops for lowering intraocular pressure in pateints with glaucoma or ocular hypertension.