US FDA Approves FoundationOne®CDx and FoundationOne®Liquid CDx as Companion Diagnostics for TALZENNA® (talazoparib) in Combination with XTANDI® (enzalutamide) to Identify Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

Original from: Foundation Medicine

Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for Pfizer’s TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) to identify patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with both BRCA mutated and non-BRCA HRR gene-mutated mCRPC.

Prostate cancer is the second most common cancer in men, with approximately 1 in 8 diagnosed during their lifetime. mCRPC 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 approximately 20-30% of patients with mCRPC. While treatment options have expanded in recent years, patients with mCRPC often continue to face poor prognosis and limited treatment options.

“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 is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. With this most recent approval, Foundation Medicine has nine FDA-approved companion diagnostic indications for prostate cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company.

“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.”

Source: US FDA Approves FoundationOne®CDx and FoundationOne®Liquid CDx as Companion Diagnostics for TALZENNA® (talazoparib) in Combination with XTANDI® (enzalutamide) to Identify Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer