FDA Denies Pfizer's (PFE) Label Expansion for Talzenna in Prostate Cancer

 Pfizer Inc. (PFE, Financial) encountered a notable obstacle when the U.S. Food and Drug Administration (FDA) declined to broaden the approved usage of its PARP inhibitor, Talzenna. While Talzenna remains on the market for treating a specific genetic type of prostate cancer, its application for patients with non-HRR mutations was not approved. This decision underscores the regulatory challenges pharmaceutical companies face in expanding treatment indications.

https://www.gurufocus.com/news/2927373/fda-denies-pfizers-pfe-label-expansion-for-talzenna-in-prostate-cancer