Posted by Michael Wonder on 15 Aug 2023
US FDA approves FoundationOne CDx as a companion diagnostic for Janssen’s Akeega (niraparib and abiraterone acetate dual action tablet) for patients with BRCA positive metastatic castration-resistant prostate cancer
14 August 2023 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now FDA approved to identify patients with metastatic castration-resistant prostate cancer harbouring BRCA1 or BRCA2 positive mutations who may benefit from treatment with Akeega.
Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx to be used as a companion diagnostic for Janssen’s Akeega (niraparib and abiraterone acetate dual action tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA mutated metastatic castration-resistant prostate cancer.
