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Search results for "ORPHAN DRUG|Designated|Treatment of malignant mesothelioma" in comments (approximate match)
Showing 1 - 4 of 4 results
Status:
Designated
Source:
FDA ORPHAN DRUG:67292
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
5,6-dihydro-5-azacytidine (DHAC) is a hydrolytically stable congener of 5-azacytidine. It exerts cytostatic action in vitro. DHAC induces DNA hypomethylation. DHAC inhibits DNA methyltransferase, thereby interfering with abnormal DNA methylation patterns that are associated with genetic instability in some tumor cells. Inhibition of this enzyme may restore expression of tumor-suppressor genes and result in antitumor activity. It was in phase II studies for the treatment of several cancers such as malignant melanoma, mesothelioma and others.
Status:
Investigational
Source:
NCT02535104: Phase 1/Phase 2 Interventional Completed Condylomata Acuminata
(2016)
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
BLA125700
(2022)
Source URL:
First approved in 2022
Source:
BLA125700
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
US Approved Rx
(1995)
Source:
NDA020451
(1995)
Source URL:
First approved in 1995
Source:
NDA020451
Source URL:
Class:
POLYMER
Targets:
Conditions:
Porfimer is a photosensitizing agent used in the photodynamic therapy (PDT) of tumors. Porfimer sodium was approved under the brand name PHOTOFRIN for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy. For the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC). For the treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated. In addition, for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. The cytotoxic and antitumor actions of PHOTOFRIN® are light and oxygen dependent. Photodynamic therapy with Porfimer sodium is a two-stage process. The first stage is the intravenous injection of the drug, which mainly is concentrated in the tumor tissues for a longer period. Illumination with 630 nm wavelength laser light constitutes the second stage of therapy. Cellular damage is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer absorbs light to form a porphyrin excited state. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. The laser treatment induces a photochemical, not a thermal, effect. The necrotic reaction and associated inflammatory responses may evolve over several days.