FDA & Regulation, Drugs & Devices Katie Coffee FDA & Regulation, Drugs & Devices Katie Coffee

FDA Approves Talzenna Plus Xtandi Earlier in Metastatic Prostate Cancer With HRR Mutations

The FDA has approved Pfizer’s Talzenna with Xtandi for men with metastatic prostate cancer that still responds to hormone therapy and carries certain DNA-repair gene mutations. The combination roughly halved the risk of progression, but it caused frequent severe anemia, and survival data are not yet mature.

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