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Key Takeaways The FDA approved updated labeling for Talzenna plus Xtandi for HRR gene-mutated metastatic castration-resistant prostate cancer, based on the TALAPRO-2 trial results. The TALAPRO-2 trial ...
Among FDA’s concerns, is that agency analysts found no OS benefit among nonmutated men when they used a different HRR status measurement than Pfizer (HR, 0.99; 95% CI, 0.67-1.47).
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