publication date: Oct. 19, 2018
Drugs & Targets Myriad’s test receives FDA approval as companion diagnostic for Pfizer’s Talzenna
FDA has approved BRACAnalysis CDx to be used by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer’s PARP inhibitor, Talzenna (talazoparib).
The test is sponsored by Myriad Genetics Inc.
Talzenna is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced.
FDA approval is based on results from the EMBRACA trial that evaluated Talzenna versus physician’s choice chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced.
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.
FDA publishes guidance on MRD as a biomarker
FDA announced the availability of the draft guidance titled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biologic Products for Treatment.”
The purpose of this guidance is to help applicants planning to use minimal residual disease as a biomarker in clinical trials … Continue reading Myriad’s test receives FDA approval as companion diagnostic for Pfizer’s Talzenna
To access this members-only content, please log in.
If you're not a subscriber why not join today?
If you believe you should be able to view this area but cannot log in, then please contact us
and we will try to rectify this issue as soon as possible.
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.