Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
Pfizer: itinakda ng FDA ang Q4 2026 PDUFA para sa TALZENNA + XTANDI mCSPC sNDA
Tinanggap ng FDA ang sNDA para sa Priority Review at nagtalaga ng PDUFA action date sa Q4 2026. Hinahanap ng filing na palawakin ang label ng TALZENNA + XTANDI mula sa mCRPC patungo sa HRR gene-mutated mCSPC. Sinusuportahan ang aplikasyon ng Phase 3 TALAPRO-3 data na nagpapakita ng 52% pagbaba sa radiographic progression o kamatayan kumpara sa placebo + XTANDI.
Mahahalagang fact
- Na-file
- Hul 22, 2026, 08:30 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Positibo
- Kumpanya
PFEPfizer- Asset
- talazoparib
- Pinagmulan
- Press release ng kumpanya
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Okt 1, 2026
- rPFS risk reduction
- 52%
Sipi mula sa source
FDA Grants Priority Review for Pfizer's TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer FDA Grants Priority Review for Pfizer's TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer FDA Grants Priority Review for Pfizer’s TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Appli