The tissue- and blood-based tests identify patients with specific gene mutations who may benefit from a combination therapy.
The Food and Drug Administration (FDA) has approved FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Pfizer’s Talzenna (talazoparib) in combination with Xtandi (enzalutamide). The tests are used to identify patients with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Talzenna is the first and only PARP inhibitor approved for use with the existing standard of care Xtandi for adult patients with both BRCA mutated and non-BRCA homologous recombination repair gene-mutated mCRPC, according to a press release from Foundation Medicine.
Prostate cancer is the second most common cancer in men, with approximately one in eight diagnosed during their lifetime. mCRPC occurs when the cancer spreads to other parts of the body despite hormone therapy that lowers testosterone. Homologous recombination repair gene mutations are present in approximately 20% to 30% of patients with mCRPC.
“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,” says Todd Druley, chief medical officer at Foundation Medicine, in a release. “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 offers an FDA-approved portfolio of tissue- and blood-based genomic profiling tests. With these latest approvals, the company has nine FDA-approved companion diagnostic indications for prostate cancer and more than 100 approved companion diagnostic indications in total.
“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,” says Courtney Bugler, CEO of ZERO Prostate Cancer, in a release. “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.”
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