Pfizer’s TALZENNA Plus XTANDI FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment Setting
The FDA expanded approval of Pfizer's TALZENNA plus XTANDI to HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive (mHSPC) prostate cancer, moving the combination into an earlier line of treatment. The approval rests on the Phase 3 TALAPRO-3 study of 599 patients, which showed a 52% reduction in the risk of radiographic progression or death (HR 0.48, p<0.0001) and 77% progression-free at three years.
Key figures
- Drug Name
- TALZENNA (talazoparib) plus XTANDI (enzalutamide)
- Phase Of Trial
- Phase 3
- Rfs hazard ratio
- 0.48
- Talapro3 patients
- 599
- Grade3plus anemia rate
- 51%
- Anemia discontinuation rate
- 5%
- Progression free at 3 years
- 77%
- Risk reduction radiographic progression or death
- 52%
AI analysis
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