BOSTON, June 1, 2026
Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) has approved both FoundationOne® CDx and FoundationOne® Liquid CDx as companion diagnostics for Pfizer’s TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide). The approvals enable healthcare providers to identify patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who may benefit from the targeted treatment combination. The milestone further strengthens Foundation Medicine’s leadership in precision oncology and expands access to personalized treatment strategies for advanced prostate cancer patients.
FDA Approval Expands Precision Medicine Options in Prostate Cancer
The newly approved companion diagnostic indications support the use of TALZENNA plus XTANDI in adult patients with both BRCA-mutated and non-BRCA HRR gene-mutated mCRPC. Metastatic castration-resistant prostate cancer represents an advanced stage of disease in which tumors continue to progress despite hormone therapy aimed at lowering testosterone levels. HRR gene mutations are estimated to occur in approximately 20% to 30% of mCRPC patients, making genomic testing increasingly important for treatment selection. The approval allows physicians to use either tissue-based or blood-based comprehensive genomic profiling to identify eligible patients and guide personalized treatment decisions.
Foundation Medicine Strengthens Companion Diagnostic Leadership
With these approvals, Foundation Medicine now holds nine FDA-approved companion diagnostic indications in prostate cancer, more than any other company in the field. The company’s portfolio exceeds 100 FDA-approved companion diagnostic indications overall, highlighting its dominant position in comprehensive genomic profiling. FoundationOne CDx analyzes 324 genes using tumor tissue samples, while FoundationOne Liquid CDx evaluates the same broad genomic landscape using circulating cell-free DNA from blood samples. Together, the tests provide flexible diagnostic options that help ensure more patients can access biomarker-driven treatment strategies regardless of tissue availability.
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Addressing Unmet Needs in Advanced Prostate Cancer Care
Prostate cancer remains the second most common cancer among men, with approximately one in eight men diagnosed during their lifetime. Despite recent therapeutic advances, patients with metastatic castration-resistant disease often face limited treatment options and poor long-term outcomes. Foundation Medicine emphasized that expanding access to high-quality genomic testing is critical as more targeted therapies enter the market. Patient advocacy groups also welcomed the approvals, noting that broader access to biomarker testing can help reduce disparities in care and ensure that patients receive treatment plans tailored to the genetic characteristics of their disease. The latest FDA approvals reinforce the growing role of precision medicine in improving outcomes for patients with advanced prostate cancer.
Source: Foundation Medicine press release
