`label-strategy`POST

Generate a precedent-backed regulatory label strategy report.

Analyzes approved label precedents, safety expectations, competitor labels, evidence-to-claim requirements, and regulatory risks for a drug asset and indication. Generated language is strategic and not approved labeling.

Endpoint

POST https://api.frontwind.ai/v1/agents/label-strategy

Example

curl -X POST https://api.frontwind.ai/v1/agents/label-strategy \
  -H "Authorization: Bearer fw_live_..." \
  -H "Content-Type: application/json" \
  -d '{ "asset_name": "FW-101", "indication": "relapsed/refractory multiple myeloma", "modality": "bispecific antibody", "mechanism_of_action": "BCMA x CD3 T-cell engagement", "target": "BCMA", "development_stage": "Phase 2", "geography": "FDA", "clinical_trial_data": { "ORR": "62%", "CR": "28%", "CRS": "55%", "Grade3_Infections": "18%" }, "endpoints": [ "ORR", "DoR", "CR" ], "competitor_assets": [ "teclistamab", "elranatamab", "idecabtagene vicleucel" ] }'

Request body

Field	Type	Required	Description
`asset_name`	`string`	Yes
`indication`	`string`	Yes
`modality`	`string`	Yes
`mechanism_of_action`	`string`	Yes
`target`	`string`	Yes
`development_stage`	`string`	Yes
`geography`	`string`	Yes	Regulatory geography, e.g. FDA, EMA, PMDA.
`clinical_trial_data`	`object`	No
`endpoints`	`array`	No
`biomarker`	`string`	No
`line_of_therapy`	`string`	No
`comparator`	`string`	No
`safety_data`	`object`	No
`dosing_information`	`string`	No
`competitor_assets`	`array`	No
`prior_regulatory_feedback`	`object`	No
`use_cache`	`boolean`	default false

Response data

Field	Type	Description
`executive_summary`	`object`
`proposed_indication_language`	`object`
`likely_label_restrictions`	`array`
`safety_warning_expectations`	`object`
`competitor_label_comparison`	`array`
`evidence_to_claim_mapping`	`array`
`label_scenarios`	`array`
`regulatory_risks`	`array`
`risk_scores`	`object`
`recommended_next_steps`	`array`
`precedents`	`array`
`sources`	`array`
`warnings`	`array`

Example response

{
  "ok": true,
  "agent": "label-strategy",
  "data": {
    "executive_summary": {
      "likely_regulatory_positioning": "Accelerated approval may be plausible if response durability is compelling in a heavily pretreated population [1][2].",
      "expected_label_scope": "Adult relapsed or refractory multiple myeloma after multiple prior lines of therapy [1][2].",
      "source_ids": [
        "1",
        "2"
      ]
    },
    "proposed_indication_language": {
      "language": "Treatment of adult patients with relapsed or refractory multiple myeloma after at least three prior lines of therapy [1][2].",
      "confidence": "Medium",
      "confidence_score": 65,
      "source_ids": [
        "1",
        "2"
      ]
    },
    "regulatory_risks": [
      {
        "risk": "accelerated approval dependency",
        "severity": "High",
        "mitigation": "Plan confirmatory randomized trial with mature DoR and PFS follow-up.",
        "source_ids": [
          "1",
          "2"
        ]
      }
    ],
    "risk_scores": {
      "claim_feasibility_score": 65,
      "regulatory_risk_score": 70,
      "label_breadth_score": 55,
      "safety_burden_score": 75,
      "source_ids": [
        "1",
        "2"
      ]
    },
    "sources": [
      {
        "id": "1",
        "title": "TECVAYLI prescribing information",
        "url": "https://www.accessdata.fda.gov/",
        "source_type": "FDA label",
        "relevance": "BCMA bispecific label precedent"
      },
      {
        "id": "2",
        "title": "ELREXFIO prescribing information",
        "url": "https://www.accessdata.fda.gov/",
        "source_type": "FDA label",
        "relevance": "BCMA bispecific label precedent"
      }
    ],
    "warnings": [
      "Generated language is inferred strategy, not approved labeling."
    ]
  },
  "elapsed_s": 42
}