FDA approves Talzenna with Xtandi for HRR gene-linked metastatic prostate cancer

The US Food and Drug Administration has approved Talzenna (talazoparib) with Xtandi (enzalutamide) to treat adults with metastatic prostate cancer linked to a mutation in HRR genes. The approval expands the use of Pfizer's combination to an earlier treatment line, and use is tied to genetic testing.

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• The approval covers adults with metastatic prostate cancer linked to an HRR gene mutation who have not received androgen pathway drugs or who are still responding to them.

  «The FDA approved Talzenna plus Xtandi for adults with HRR-mutated metastatic prostate cancer that has not been treated with, or is still responding to, androgen pathway drugs.»

  Cure Today
• Coverage described the approval as an expansion of the combination's use to an earlier treatment line in hormone-sensitive prostate cancer.

  «Pfizer’s talazoparib-enzalutamide combination moves to earlier line in prostate cancer, with eligibility tied to genetic testing and immature survival data.»

  Yahoo Finance Australia • Pharmaceutical Executive
• Eligibility is tied to genetic testing, and the survival data available so far remain immature.

  «with eligibility tied to genetic testing and immature survival data»

  Pharmaceutical Executive

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