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In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Currently, a lot of PCR and hybridization assays have been approved by FDA as in vitro diagnostics. [47] NGS assays, however, are still at an early stage in clinical diagnostics. [48] To do the molecular diagnostic test for cancer, one of the significant issue is the DNA sequence variation detection.
Pharmacogenomics Biomarkers in Drug Labelling: A table that identifies which FDA-approved drugs have pharmacogenomics-related warning labels [84] SNPedia: A wiki-based bioinformatics database of SNPs [85] [86] Pharmacogenomics Research Network (PGRN)
A companion diagnostic (CDx) [1] is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. [2]Companion diagnostics are co-developed with drugs to aid in selecting or excluding patient groups for treatment with that particular drug based on their biological characteristics that determine responders and non-responders to the therapy.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
Midostaurin was approved by the FDA in April 2017 for the treatment of adult patients with newly diagnosed AML who are positive for oncogenic FLT3, in combination with chemotherapy. [15] The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.
An imaging biomarker is a biologic feature, or biomarker detectable in an image. [1] In medicine, an imaging biomarker is a feature of an image relevant to a patient's diagnosis. For example, a number of biomarkers are frequently used to determine risk of lung cancer .
A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. [2] RMAT goes beyond breakthrough therapy features by allowing for accelerated approval of drugs based on surrogate endpoints. A surrogate endpoint is a biomarker that substitutes for a direct endpoint, such as clinical benefit. [3]