FDA Oks FoundationOne CDx and Liquid CDx for Use With Olaparib/Abiraterone in Prostate Cancer

Two prostate cancer cells in the final stage of cell division: ©PRB ARTS - stock.adobe.com

• The FDA has approved the FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for the combination of olaparib (Lynparza) and abiraterone (Zytiga) with prednisone or prednisolone for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
• This approval follows 2 previous approvals of the FoundationOne CDx as companion diagnostics for olaparib in mCRPC.
• The availability of tissue- and liquid-based diagnostic tools provides greater access to genomic testing for patients.

The FoundationOne CDx and FoundationOne Liquid CDx have been approved by the FDA for companion use with olaparib, abiraterone, and prednisone or prednisolone in patients with BRCA-mutated mCRPC.¹

“This approval reinforces the importance of testing for genomic mutations at metastatic diagnosis to help guide treatment decisions,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, in a press release. “Our high-quality tissue and liquid biopsy companion diagnostic tests will allow more patients to access genomic testing, regardless of specimen type, and will simplify complex decisions by generating the best information to enable better decision-making. There is a critical unmet need for first-line treatment options for patients with BRCA-mutated metastatic castration-resistant prostate cancer and this combination therapy is an important advancement.”

This approval marks Foundation Medicine’s seventh FDA-approved companion diagnostic in prostate cancer. In May 2020, the FDA approved the FoundationOne CDx in patients with homologous recombination repair gene-mutated mCRPC who had progressed following treatment with enzalutamide (Xtandi) or abiraterone.² In November 2020, the Liquid CDx was approved as a companion diagnostic for olaparib to identify patients with mCRPC harboring BRCA1, BRCA2, or ATM alterations.³

The FoundationOne companion diagnostics can analyze over 300 cancer-related genes using either blood or tissue samples. The approval of both tissue- and blood-based diagnostic tools provides greater access and flexibility for patients to benefit from genomic testing, particularly with the poor prognosis associated with BRCA-mutated mCRPC.¹

“This is an important milestone for men with aggressive prostate cancer,” said Courtney Bugler, president and chief executive officer of ZERO Prostate Cancer, in the press release. “Biomarker testing is an important tool for patients and families to help facilitate personalized treatment decision making, and we applaud Foundation Medicine for these additional companion diagnostic indications.”

REFERENCES:

1. US Food and Drug Administration approves FoundationOne®CDx and FoundationOne®Liquid CDx as companion diagnostics for Lynparza® (olaparib) in combination with abiraterone for patients with BRCA-mutated metastatic castration-resistant prostate cancer. News release. Foundation Medicine. September 3, 2024. Accessed September 4, 2024. https://tinyurl.com/3bzb5wab

2. Foundation Medicine receives FDA approval for FoundationOne®CDx as the companion diagnostic for LYNPARZA® to identify patients with HRR-mutated metastatic castration-resistant prostate cancer. News release. Foundation Medicine. May 21, 2020. Accessed September 4, 2024. https://tinyurl.com/pm6a9k7c

3. Foundation Medicine expands indication for FoundationOne®Liquid CDx to be used as a companion diagnostic for LYNPARZA®. News release. Foundation Medicine. November 10, 2020. Accessed September 4, 2024. https://tinyurl.com/pkny49ar