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FDA announced the availability of the draft guidance titled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biologic Products for Treatment.”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 conducted under an Investigational New Drug Application to support marketing approval of drugs and biological products for the treatment of specific hematological malignancies.

This guidance specifically describes for applicants the development of MRD as a biomarker for regulatory use, technology considerations including assay considerations and sampling considerations, disease specific considerations, and regulatory submissions which utilize MRD.

MRD is a measure … Continue reading Myriad’s test receives FDA approval as companion diagnostic for Pfizer’s Talzenna

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