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Chugai CDx for AstraZeneca Breast Cancer Combination Therapy Receives Japanese Approval

NEW YORK – Chugai Pharmaceutical announced Wednesday that Japan's Ministry of Health, Labour, and Welfare has approved Roche's FoundationOne CDx Cancer Genomic Profile test for identifying patients who may be eligible for AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant). 

The test is approved to identify patients with advanced unresectable or recurrent HR-positive, HER2-negative breast cancer with specific PIK3CA, AKT1 or PTEN alterations, Chugai, a member of the Roche Group, said in a statement. 

Roche subsidiary Foundation Medicine developed the FoundationOne test, while Chugai is the marketing authorization holder of the FoundationOne CDx assay in Japan. 

"By using this test as a companion diagnostic, approximately half of patients with advanced HR-positive, HER2-negative breast cancer will be able to consider a more appropriate treatment option," Chugai President and CEO Osamu Okuda said in a statement. 

The next-generation sequencing-based assay is used for the detection of substitutions, insertions and deletions, and copy number alterations in 324 genes and gene rearrangements in solid tumor samples. It also detects genomic signatures such as microsatellite instability and tumor mutational burden. It is used with formalin-fixed, paraffin-embedded tumor tissue specimens. 

FoundationOne CDx was approved by the US Food and Drug Administration as a companion diagnostic for the drug combination in November.