Foundation Medicine tallied another nod from the FDA for one of its genomic profiling tests that searches for specific biomarkers in tumor tissue samples.
This time, it’s Pfizer’s prostate cancer combo Talzenna (talazoparib) and Xtandi (enzalutamide), which can identify patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), the company said in a June 1 press release.
With more than a hundred previous Cdx approvals on its ledger, the latest marks the ninth FDA-approved companion diagnostic indications for prostate cancer specifically. The company touts Talzenna as the first and only PARP inhibitor approved for use with an existing standard of care (Xtandi) in adult patients with both BRCA-mutated and non-BRCA HRR gene-mutated mCRPC.
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“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,” Todd Druley, Foundation’s chief medical officer, said in a statement. “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’s tissue- and blood-sample versions analyze more than 300 cancer-related genes to pinpoint biomarkers that may make an individual particularly receptive to certain treatments.
In early May, Foundation teamed up with Fulgent Genetics to offer a new dx test that can identify a person’s genetic makeup that can aid in determining how they metabolize and process drugs.
That deal came just weeks after Foundation strengthened its ties with Bristol Myers Squibb to identify patients with homozygous MTAP deletion. By detecting such a deletion would help detect patients for targeted therapies and better matches them with Bristol Myers Squibb’s experimental drug.
