FDA Accepts Supplementary Premarket Approval Application for BRACAnalysis CDx for Metastatic Breast Cancer
Posted: Tuesday, July 3, 2018
The U.S. Food and Drug Administration (FDA) has accepted a supplementary premarket approval application for BRACAnalysis CDx to be used as a companion diagnostic with the PARP inhibitor talazoparib. The new drug application for talazoparib has been granted Priority Review by the FDA.
These submissions are based on results from the EMBRACA trial, which evaluated talazoparib vs chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. The primary results of the study were presented at the San Antonio Breast Cancer Symposium (Abstract GS6-07) in December 2017.
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes. The test uses genomic DNA obtained from whole-blood specimens collected in ethylenediamine tetraacetic acid.
Single-nucleotide variants and small insertions and deletions are identified by polymerase chain reaction and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex polymerase chain reaction assay. Results of the test are used as an aid to identify patients with deleterious or suspected deleterious germline BRCA variants who may be candidates for treatment with a PARP inhibitor.
