Skip to main content
Premium Trial:

Request an Annual Quote

Chugai Nabs Japanese Approval for CDx for Pfizer's Talzenna

NEW YORK – Chugai Pharmaceutical said Monday that Japan's Ministry of Health, Labour, and Welfare has approved Roche's FoundationOne CDx Cancer Genomic Profile for determining which patients with BRCA mutation-positive castration-resistant prostate cancer with distant metastases would benefit from treatment with Pfizer's Talzenna capsules (talazoparib tosylate).

Chugai, which is a member of the Roche Group, said the companion diagnostic is used for the detection of BRCA1 and BRCA2 genetic mutations to aid decisions on whether to treat patients with the PARP inhibitor Talzenna. Foundation Medicine, a subsidiary of Roche, developed the FoundationOne test. Chugai is the marketing authorization holder of the FoundationOne CDx in Japan.

"Castration-resistant prostate cancer is considered an advanced cancer that is difficult to treat, and there is a high unmet medical need," Chugai President and CEO Osamu Okuda said in a statement. "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."

FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing-based test that is used for the detection in solid tumor samples of substitutions, insertions and deletions, and copy number alterations in 324 genes and gene rearrangements as well as genomic signatures such as microsatellite instability and tumor mutational burden. It is used with formalin-fixed, paraffin-embedded tumor tissue specimens.