BOSTON — Foundation Medicine said the U.S. Food and Drug Administration approved its FoundationOne CDx and FoundationOne Liquid CDx tests as companion diagnostics for Pfizer’s Talzenna in combination with Xtandi for certain patients with metastatic castration-resistant prostate cancer.
The approvals allow the tests to be used to identify patients with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who may be eligible for treatment with Talzenna, also known as talazoparib, in combination with Xtandi, also known as enzalutamide.
Foundation Medicine said Talzenna is the first and only PARP inhibitor approved for use with an existing standard of care, Xtandi, for adults with both BRCA-mutated and non-BRCA HRR gene-mutated metastatic castration-resistant prostate cancer.
Prostate cancer is the second most common cancer in men, with about one in eight diagnosed during their lifetime. Metastatic castration-resistant prostate cancer occurs when prostate cancer grows and spreads to other parts of the body despite hormone therapy that lowers testosterone. HRR gene mutations are present in about 20% to 30% of patients with metastatic castration-resistant prostate cancer.
“Every patient deserves clear, personalized answers when it comes to their treatment plan, but one-size-fits all approaches do not work for everyone. As more targeted therapies become available to treat mCRPC, it is incredibly important to have high-quality tissue- and blood-based companion diagnostics available to best inform personalized treatment plans for each unique patient,” said Todd Druley, M.D., Ph.D., chief medical officer at Foundation Medicine. “These two approvals further strengthen Foundation Medicine’s leadership in companion diagnostics and underscore the critical role of comprehensive genomic profiling in connecting patients with targeted treatment options.”
Foundation Medicine said it is the only company with an FDA-approved portfolio of tissue- and blood-based comprehensive genomic profiling tests. With the latest approvals, the company said it now has nine FDA-approved companion diagnostic indications for prostate cancer and more than 100 approved companion diagnostic indications overall.
“Too many prostate cancer patients still can’t access the biomarker tests that should guide their treatment, not because the tests don’t exist, but because access isn’t consistent or equitable,” said Courtney Bugler, president and CEO of ZERO Prostate Cancer. “Biomarker testing gives patients and their families the clarity they need to understand their diagnosis and make informed decisions about care. Every person deserves access to personalized treatment information, regardless of their doctor, their diagnosis, or their ZIP code.”
