Chugai obtained approval from the Ministry of Health

Chugai obtains approval for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic for PARP inhibitor, Talazoparib

Chugai Pharmaceutical Co Ltd. announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on February 2, 2024, for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic for Pfizer Japan Inc's polyadenosine 5’ diphosphate ribose polymerase (PARP) inhibitor, Talzenna capsules (generic name: talazoparib tosilate), which is approved for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases.

“We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for talazoparib for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases,” said Chugai’s president and CEO, Dr. Osamu Okuda. “Castration-resistant prostate cancer is considered an advanced cancer that is difficult to treat, and there is a high unmet medical need. By expanding companion diagnostics, we aim to increase the value of this test for smooth consideration of treatment plans, improve access for prostate cancer patients, and contribute to the advancement of cancer treatment.”

This approval enables the detection of BRCA1/2 gene mutations using the FoundationOne CDx Cancer Genome Profile to assist of the decision to use talazoparib for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases. The efficacy and safety of combination therapy of talazoparib and enzalutamide for BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases was evaluated in the global phase III study TALAPRO-2. Pfizer Japan Inc. obtained approval from the MHLW on January 18th, 2024.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of Comprehensive Genome Profile.

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumour mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumour tissue specimens.

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