'We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic of olaparib for prostate cancer,' said Dr.
The approval aims to expand FoundationOne CDx Cancer Genomic Profile for use as a companion diagnostic to identify prostate cancer patients with BRCA1/2 alterations who could benefit from the treatment with olaparib whose disease progressed after treatment with enzalutamide or abiraterone by detecting BRCA1/2 gene alterations. The efficacy and safety of olaparib in mCRPC patients with BRCA1/2 alterations were investigated in the Phase III PROfound study and
As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.
Approval information The underlined part has been newly added.
Intended uses or indications
The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
About FoundationOne CDx Cancer Genomic Profile
Developed by
About BRCA alterations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.1-4
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
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