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AstraZeneca says the recommendation follows late?stage trial results showing the combination helps delay disease progression.
The FDA advisory committee recommended Truqap's benefit-risk profile for PTEN-deficient prostate cancer.
KEY POINTS
- Truqap, combined with abiraterone and hormone therapy, delays disease progression in late-stage trials.
- This is the first targeted treatment shown to benefit PTEN-deficient metastatic hormone-sensitive prostate cancer.
- The FDA's decision follows earlier acceptance of AstraZeneca's application for Truqap.
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