Which tier in Precise Tumor indicates FDA-approved therapy in the same cancer?

Which tier in Precise Tumor indicates FDA-approved therapy in the same cancer?

• A. Tier I
• B. Tier II
• C. Tier III
• D. Tier IA

Answer: (D)

In this tiering system, the highest level of evidence and regulatory support for using a targeted therapy is when the drug is FDA-approved for the exact cancer being treated with that biomarker. This is what Tier IA represents—the therapy is on-label for that specific cancer, providing the strongest, most actionable evidence for use. It means there is regulatory approval and established safety and efficacy in that exact tumor context. Other tiers cover scenarios like approvals in different cancers with the same biomarker or evidence from studies that aren’t as definitive; they are informative but not as directly applicable as an on-label, cancer-specific approval.

In this tiering system, the highest level of evidence and regulatory support for using a targeted therapy is when the drug is FDA-approved for the exact cancer being treated with that biomarker. This is what Tier IA represents—the therapy is on-label for that specific cancer, providing the strongest, most actionable evidence for use. It means there is regulatory approval and established safety and efficacy in that exact tumor context.

Other tiers cover scenarios like approvals in different cancers with the same biomarker or evidence from studies that aren’t as definitive; they are informative but not as directly applicable as an on-label, cancer-specific approval.