FDA approves FoundationOneLiquid CDx for niraparib/abiraterone in mCRPC

The FDA has approved the liquid biopsy test FoundationOneLiquid CDx for use as a companion diagnostic in identifying patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) who may benefit from treatment with niraparib and abiraterone acetate dual action tablets (Akeega), Foundation Medicine announced in a news release.¹

Foundation Medicine now has 5 FDA-approved companion diagnostics indicated for prostate cancer.

This announcement follows an earlier FDA decision to grant approval to the company’s tissue-based comprehensive genomic profiling test FoundationOne CDx as a companion diagnostic for the same therapy and indication in August 2023.² Niraparib and abiraterone acetate is a dual-action tablet approved for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated mCRPC.

“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 the news 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, health care providers can feel confident they have accurate genomic information at their fingertips to guide treatment decisions for patients.”

According to the company, the FoundationOneLiquid CDx test analyzes “324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients.”¹ The test is designed as a companion diagnostic to identify patients in whom treatment with specific therapies may be appropriate. The liquid biopsy test is approved as a companion diagnostic across several indications in prostate cancer, non-small cell lung cancer, breast cancer, colorectal cancer, and a pan tumor indication for NTRK1/2/3 fusions.

With the approval of FoundationOneLiquid CDx, Foundation Medicine now has 5 FDA-approved companion diagnostics indicated for prostate cancer. FoundationOneLiquid CDx was approved as a companion diagnostic for patients with BRCA-positive prostate cancer who may respond rucaparib (Rubraca) in August 2020.³ The test was also approved in November 2020 for identifying patients with mCRPC harboring BRCA1, BRCA2,and/or ATM alterations who may benefit from treatment with olaparib (Lynparza).⁴

FoundationOne CDx, the tissue biopsy test, is approved as a companion diagnostic in identifying patients who may be appropriate for treatment with olaparib (Lynparza) and niraparib plus abiraterone acetate.⁵

“Men with aggressive prostate cancer need and deserve more options,” said Courtney Bugler, president and CEO of ZERO Prostate Cancer, in the news release.¹ “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 FoundationOneLiquid 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. Published online and accessed July 1, 2024. https://www.foundationmedicine.com/press-release/fda-approval-foundationone-liquid-cdx-akeega

2. U.S. Food and Drug Administration (FDA) approves FoundationOneCDx 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://www.foundationmedicine.com/press-releases/u.s.-food-and-drug-administration-%28fda%29-approves-foundationone%C2%AEcdx-as-a-companion-diagnostic-for-janssen%E2%80%99s-akeega%E2%84%A2-%28niraparib-and-abiraterone-acetate-dual-action-tablet%29-for-patients-with-brca-po

3. FDA approves Foundation Medicine's FoundationOneLiquid CDx, a comprehensive pan-tumor liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer. News release. Foundation Medicine, Inc. August 27, 2020. Accessed July 1, 2024. https://www.foundationmedicine.com/press-releases/fda-approves-foundation-medicine%27s-foundationone%C2%AEliquid-cdx%2C-a-comprehensive-pan-tumor-liquid-biopsy-test-with-multiple-companion-diagnostic-indications-for-patients-with-advanced-cancer

4. Foundation Medicine expands indication for FoundationOneLiquid CDx to be used as a companion diagnostic for LYNPARZA. News release. Foundation Medicine, Inc. November 10, 2020. Accessed July 1, 2024. https://www.foundationmedicine.com/press-releases/foundation-medicine-expands-indication-for-foundationone%C2%AEliquid-cdx-to-be-used-as-a-companion-diagnostic-for-lynparza%C2%AE

5. FoundationOne CDx. Foundation Medicine. Accessed July 1, 2024. https://www.foundationmedicine.com/test/foundationone-cdx