The FDA nod marks a step forward in precision oncology, linking molecular diagnostics more tightly to therapy selection for advanced prostate cancer
The decision was driven by results from the Phase III CAPItello-281 trial,
This marks one of the most closely watched oncology readouts at this year’s medical congress
Despite the strong results, investigators cautioned that the study has limitations, including its open-label Phase II design, lack of randomization, and reliance on a historical external control arm
The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
The trial met its primary endpoint, with the combination therapy demonstrating a “statistically significant and clinically meaningful” improvement in radiographic progression-free survival
The study hit its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus XTANDI
PEACE-3 is a strong example of how academic cooperative research can help advance progress for complex diseases such as metastatic prostate cancer
Prostate cancer is one of the fastest-growing cancers in India, with approximately 37,948 new cases each year
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