FDA Approves FoundationOne Liquid CDx for Niraparib/Abiraterone in Aggressive Prostate Cancer

• FoundationOne Liquid CDx is now an FDA-approved companion device for niraparib (zejula) and abiraterone acetate (Akeega) in deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
• The tissue-based FoundationOne CDx was approved in August 2023 for the same therapy and indication.
• This minimally invasive liquid biopsy allows for more patients to be easily screened for BRCA mutations.

The FDA has approved the FoundationOne Liquid CDx as a companion device for the combination treatment of niraparib and abiraterone acetate for the treatment of deleterious or suspected deleterious BRCA-mutated metastatic mCRPC.¹

Niraparib/abiraterone is the first and only FDA-approved dual PARP inhibitor/hormone therapy. In August 2023, the FoundationOne CDx, a tissue-based comprehensive genomic profiling test, was approved for the same therapy and indication.²

“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, MD, PhD, chief medical officer at Foundation Medicine, in a press release.¹ “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.”

The FoundationOne Liquid CDx analyzes more than 300 cancer-related genes from circulating cell-free DNA isolated from a blood sample. The Liquid CDx also has additional companion diagnostic indications in non–small cell lung cancer, prostate cancer, breast cancer, colorectal cancer, and NTRK1/2/2 fusions.

BRCA1- and BRCA2- mutated mCRPC make up about 11% of prostate cancer diagnoses and is a more aggressive form of the disease. Many patients still face a poor prognosis, according to Foundation Medicine.

“Men with aggressive prostate cancer need and deserve more options,” said Courtney Bugler, president and chief executive officer of ZERO Prostate Cancer, in a press release. “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.”

REFERENCES:

1. 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. News release. Foundation Medicine, Inc. July 1, 2024. Accessed July 1, 2024. https://tinyurl.com/ytk3a7us

2. 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. Foundation Medicine, Inc. August 15, 2023. Accessed July 1, 2024. https://tinyurl.com/mt9abku8