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| Title | Truqap (capivasertib) FDA Drug Label | ||||||||||||
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| URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218197 | ||||||||||||
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| Molecular Profile | Treatment Approach |
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| Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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| Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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| Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PTEN negative | prostate cancer | sensitive | Abiraterone + Capivasertib + Prednisone | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (CAPItello-281) that supported FDA approval, addition of Truqap (capivasertib) to Zytiga (abiraterone), Adasone (prednisone), and androgen deprivation therapy significantly improved radiographic progression-free survival (33.2 vs 25.7 mo, HR 0.81, p=0.034) compared to placebo in patients with PTEN-deficient (>/=90% tumor cells with no cytoplasmic PTEN by IHC) metastatic hormone-sensitive prostate cancer (PMID: 41120017; NCT04493853). | detail... 41120017 detail... |