Myriad Genetics Inc. said FDA has accepted its supplementary premarket approval application for BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s PARP inhibitor, talazoparib. The New Drug Application for talazoparib has been granted priority review by the FDA and has a Prescription Drug User Fee Act goal date of December 2018.
Myriad’s sPMA and Pfizer’s NDA submissions are based on results from the Pfizer-sponsored EMBRACA trial, which evaluated talazoparib versus 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 in Dec 2017.
Myriad estimates there are approximately 125,000 patients with metastatic breast cancer who would immediately qualify for the BRACAnalysis CDx test, followed by 60,000 new patients per year on an ongoing basis.
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 using genomic DNA obtained from whole blood specimens collected in EDTA.
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 PCR. Results of the test are used as an aid in identifying cancer patients with deleterious or suspected deleterious germline BRCA variants who may be candidates for a PARP inhibitor. This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located in Salt Lake City.
