U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 151 - 160 of 211 results

Status:
Possibly Marketed Outside US

Class (Stereo):
CHEMICAL (ABSOLUTE)

18F-FET (18F-Fluoroethyl-L-tyrosine) is a radiolabelled amino acid. It penetrates the blood-brain barrier by a specific amino acid transport system. In the brain, it is taken up into upregulated tumoral cells but not incorporated into proteins. It is used as a biomarker for positron emission tomography for imaging brain tumors, where it has higher specificity than 18F-FDG.
Status:
Possibly Marketed Outside US

Class (Stereo):
CHEMICAL (ACHIRAL)



Rociletinib is a novel, potent, small molecule, third generation TKI that irreversibly binds and inhibits EGFR with the common activating (L858R, Del19) and T790M resistance mutations. The proposed indication of rociletinib is for the treatment of patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the T790M mutation as detected by an FDA approved test. The results from two Phase 2 studies show that rociletinib 625 mg BID treatment has a favorable benefit:risk profile in patients with recurrent T790M-positive mutant EGFR NSCLC based on clinically meaningful and durable responses and a well-established and acceptable safety profile in this patient population with terminal lung cancer. In May 2016, Clovis Oncology, Inc. announced it has terminated enrollment in all ongoing sponsored studies of rociletinib, including TIGER-3, after the company was notified at meeting with the FDA that it could anticipate receiving a Complete Response Letter (CRL) for the rociletinib NDA on or before the PDUFA date of June 28, 2016. Clovis has also withdrawn its Marketing Authorization Application of rociletinib with European regulatory authorities.
Status:
Possibly Marketed Outside US
Source:
SUPECT by Ilyang Pharmaceutical
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Radotinib (Supect) was developed and approved in Korea as a second-line Chronic Myeloid Leukemia treatment. The drug supresses cancer cells proliferation by inhibitiing BCR-ABL1 kinase which is a driver of Philadelphia chromosome-positive (Ph+) leukemia.
Status:
Investigational
Source:
NCT00851045: Phase 2 Interventional Completed Colorectal Cancer (CRC)
(2009)
Source URL:

Class:
PROTEIN

Showing 151 - 160 of 211 results