FDA Approves FoundationOne CDx to Identify Akeega Candidates with BRCA+ mCRPC


  • FoundationOne CDx is a next-generation sequencing–based in vitro diagnostic device that detects insertions, alterations, and deletions.

  • FoundationOne CDx can identify over 324 genes along with select gene rearrangements, and signatures.

  • The BRCA 1/2 mutations identified by the FoundationOne CDx under its new indication occur in 10% to 15% of metastatic castration resistant prostate cancer (mCRPC) diagnoses.

The FDA has granted approval to the FoundationOne CDx, which is indicated for use as a companion diagnostic (CDx) for the niraparib and abiraterone acetate dual action tablet (Akeega).1

Over 30 indications have been granted for the FoundationOne CDx. The assay can detect over 300 cancer-related genes. Developer of the FoundationOne CDx, Foundation Medicine, Inc, also has developed more than 60% of the next-generation sequencing (NGS)-based assays approved in the United States, according to a press release.

The niraparib and abiraterone acetate dual action tablet is newly FDA approved for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Findings from the phase 3 MAGNITUDE study (NCT03748641) served as basis for the approval.2,3

“With such a rapidly evolving therapeutic landscape in prostate cancer, high-quality companion diagnostics are important tools to support oncologists in the development of personalized treatment plans for each unique patient,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, in the press release.

In the MAGNITUDE study, all 765 patients with mCRPC were screened prospectively for HRR gene alterations, including ATM, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, or PALB2. To conduct this molecular testing, the FoundationOne CDx was used along with 3 other assays: Resolution HRD™ liquid biopsy assay AmoyDx® blood and tissue assays. Using FoundationOne CDx, 225 patients with BRCA 1/2 mutations were identified in the study.3

PC-3 human prostate cancer cells| Image Credit: © heitipaves - www.stock.adobe.com

Cells, prostate cacner | Image Credit: © heitipaves - www.stock.adobe.com

The study ultimately showed clinically significant improvement in radiographic progression-free survival with when the dual action tablet was added to prednisone compared with abiraterone acetate and prednisone alone in BRCA-positive mCRPC, which underscored the importance of molecular testing.

“This companion diagnostic specifically will help enable broader access to an important new therapy option in BRCA 1/2-positive mCRPC. We look forward to ongoing collaboration with Janssen to help bring more treatment options to patients facing a cancer diagnosis,” said Levy, in the press release.1


1. U.S. Food and Drug Administration (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. News release. August 14, 2023. Accessed August 15, 2023. https://www.foundationmedicine.com/press-releases/77d12149-fab5-443c-8e7a-1b46085bb1c2

2. https://www.annalsofoncology.org/article/S0923-7534(23)00757-3/fulltext#appsec1U.S. FDA approves Akeega™ (niraparib and abiraterone acetate), the first-and-only dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer. News release. August 11, 2023. Accessed August 11, 2023.

3. Chi KN, Sandhu S, Smith MR, et al. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial. Ann Oncol. 2023;S0923-7534(23)00757-3. doi:10.1016/j.annonc.2023.06.009

Related Videos
Experts on prostate cancer
Expert on prostate cancer
Experts on prostate cancer
Expert on prostate cancer
Experts on prostate cancer
Experts on prostate cancer
Experts on prostate cancer
Related Content