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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FDA & Regulation, Drugs & Devices Phillip Leblanc FDA & Regulation, Drugs & Devices Phillip Leblanc

FDA Approves Hibsago, a First-of-Its-Kind Hepatitis B Drug That Lets Some Patients Stop Treatment

The FDA has approved Hibsago (bepirovirsen), GSK's injectable antisense drug for chronic hepatitis B. In two phase 3 trials, about 19% of patients achieved a functional cure and could stop all treatment. The drug carries a boxed warning for liver reactions and low platelets.

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

FDA Grants Accelerated Approval to Dostarlimab for dMMR Rectal Cancer, Opening a Path Around Surgery

The FDA has cleared GSK's immunotherapy Jemperli for a small, genetically defined group of patients with locally advanced rectal cancer. In trials, many avoided surgery, radiation and chemotherapy entirely, but the evidence comes from single-arm studies and longer follow-up is still required.

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