Foundation Medicine’s Liquid Biopsy Test Gains FDA Approval for Prostate Cancer Treatment

Foundation Medicine, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its liquid biopsy test, FoundationOne®Liquid CDx, to be used as a companion diagnostic for AKEEGA® (niraparib and abiraterone acetate), a dual-action tablet for treating adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). This marks the first FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for this aggressive form of prostate cancer.

The FDA’s decision builds on the previous approval of FoundationOne®CDx, Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, for the same therapy and indication in August 2023.

“Men with aggressive prostate cancer need and deserve more options,” 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.”

Prostate cancer remains one of the most prevalent cancers among men. BRCA1- or BRCA2-mutated mCRPC, accounting for about 11% of diagnoses, poses significant treatment challenges and often results in poor prognosis. While tumor tissue testing is the standard for identifying BRCA mutations, not all mCRPC patients have sufficient tumor tissue for testing. The approval of FoundationOne®Liquid CDx offers a minimally invasive alternative, allowing healthcare providers to identify more patients who could benefit from AKEEGA®.

FoundationOne®Liquid CDx analyzes over 300 cancer-related genes from a blood sample, providing vital genomic insights. It has multiple companion diagnostic indications across several cancers, including non-small cell lung cancer, prostate cancer, breast cancer, and colorectal cancer.

Foundation Medicine is now the only company with five FDA-approved companion diagnostic indications for prostate cancer, cementing its position as a leader in next-generation sequencing (NGS) testing approvals.

Courtney Bugler, President and CEO of ZERO Prostate Cancer, praised the approval, saying, “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.”