The FDA today approved Myriad Genetics’ BRACAnalysis CDx as a companion diagnostic for Pfizer’s poly ADP-ribose polymerase (PARP) inhibitor Talzenna (talazoparib), which has also won agency approval.
The approval allows healthcare professionals to use BRACAnalysis CDx to identify patients with HER2-negative metastatic breast cancer (mBC) who have a germline BRCA mutation and are eligible for treatment with Talzenna.
Talzenna is indicated for adult patients with deleterious or suspected deleterious germline (inherited) BRCA-mutated HER2-negative locally advanced or mBC. To receive the treatment, patients must be selected based on an FDA-approved companion diagnostic for talazoparib.
“We estimate there are more than 60,000 patients diagnosed with or who progress to metastatic breast cancer in the United States every year who qualify for a BRACAnalysis CDx test,” Lloyd Sanders, president, Myriad Oncology, said in a statement.
The FDA based its approvals of Talzenna and BRACAnalysis CDx on results from the pivotal EMBRACA trial (NCT01945775), an open-label study that randomized 431 patients (2:1) with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine).
BRACAnalysis CDx test was shown in the EMBRACA trial to accurately identify certain patients with a germline BRCA-mutation who may benefit from Talzenna, Myriad said.
Talzenna is one of several PARP inhibitors for which Myriad has won FDA approval to use BRACAnalysis CDx as a companion diagnostic. The other two are AstraZeneca’s Lynparza (olaparib) and Tesaro’s Zejula® (niraparib). Myriad has also partnered with Clovis Oncology to develop BRACAnalysis CDx as a companion diagnostic for its approved PARP inhibitor Rubraca (rucaparib).
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 (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.
BRCAnalysis CDx is for professional use only and can only be performed at Myriad Genetic Laboratories, a single lab site located at 320 Wakara Way, Salt Lake City, UT 84108.
EMBRACA’s primary outcome measure was Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment from baseline until radiologic progressive disease or death due to any cause, up to maximum duration of 36.9 months.
In EMBRACA, all patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.