2. UroToday Home
  3. Recent Abstracts
  4. Urologic Oncology
  5. Prostate Cancer

U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for AKEEGA® (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Foundation Medicine’s liquid biopsy test can now be used in addition to its tissue biopsy test, FoundationOne®CDx, to identify more patients for whom AKEEGA® may be appropriate

Reno, Nevada (UroToday.com) -- Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for AKEEGA® (niraparib and abiraterone acetate) from Janssen Biotech, Inc, a Johnson & Johnson company, the first and only FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).1 This decision from the FDA follows the approval of FoundationOne®CDx, Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, for the same therapy and indication in August 2023.

Prostate cancer is one of the most common cancers in men.2 BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of the disease,3 occurring in approximately 11% of diagnoses.4 Despite progress in developing new treatment options for this condition, BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and patients often face a poor prognosis.5

While some BRCA1 and BRCA2 mutations are germline, somatic mutations are more common.4 While tumor tissue testing is the gold standard for identifying patients with BRCA1 or BRCA2 mutations in prostate cancer, not all patients with mCRPC have sufficient tumor tissue available for testing.6 With this approval, healthcare providers can now leverage a minimally invasive liquid biopsy to identify additional patients with BRCA mutations who may benefit from AKEEGA®.

“We know how challenging it can be to obtain a tissue sample for testing in advanced cancers such as mCRPC, making liquid biopsy an incredibly important tool in a provider’s toolbox for the development of personalized treatment plans for their patients,” said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “The approval of our liquid biopsy test, along with the previous approval for our tissue biopsy test, will enable more patients to access this important therapy option. Additionally, with the ability to leverage a liquid-based test and reflex to a tissue-based test if needed, healthcare providers can feel confident they have accurate genomic information at their fingertips to guide treatment decisions for patients.”
From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. The test has several companion diagnostic indications across non-small cell lung cancer (NSCLC), prostate cancer, breast cancer, and colorectal cancer, plus a pan tumor indication specific to NTRK1/2/3 fusions.

With today’s approval, Foundation Medicine is the only company that has five FDA-approved companion diagnostic indications for prostate cancer.7 Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.8

“Men with aggressive prostate cancer need and deserve more options,” said Courtney Bugler, President and CEO of ZERO Prostate Cancer. “We applaud Foundation Medicine’s liquid biopsy test because it empowers patients and families with more tools that can potentially help them lead longer, fuller lives.”

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

  1. AKEEGA® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
  2. Cancer.net. Prostate Cancer: Statistics. Updated March 2023. Accessed May 13, 2024. https://www.cancer.net/cancer-types/prostate-cancer/statistics
  3. Castro E, Eeles R. The role of BRCA1 and BRCA2 in prostate cancer. Asian J Androl. 2012;14(3):409-414. doi:10.1038/aja.2011.150
  4. Valsecchi AA, Dionisio R, Panepinto O, et al. Frequency of Germline and Somatic BRCA1 and BRCA2 Mutations in Prostate Cancer: An Updated Systematic Review and Meta-Analysis. Cancers. 2023; 15(9):2435. https://doi.org/10.3390/cancers15092435
  5. Messina C, Cattrini C, Soldato D, et al. BRCA Mutations in Prostate Cancer: Prognostic and Predictive Implications. J Oncol. 2020;2020:4986365. Published 2020 Sep 7. doi:10.1155/2020/4986365
  6. Chi KM, Barnicle A, Sibilia C, et al. Detection of BRCA1, BRAC2 and ATM alterations in matched tumor tissue and circulating tumor DNA in patients with prostate cancer screened in PROfound. Clin Cancer Res. 2023;29(1):81-9. https://doi.org/10.1158/1078-0432.CCR-22-0931
  7. Data on File, Foundation Medicine, Inc. 2024
  8. Data on File, Foundation Medicine, Inc., data as of March 2024

Source: Foundation Medicine, Inc. (2024). U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for AKEEGA® (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer [Press release]. https://www.foundationmedicine.com/press-release/fda-approval-foundationone-liquid-cdx-akeega.