Source ID: D27
Original URL: https://newsroom.astellas.com/2026-09-18-padcev-in-combination-with-keytruda-receives-positive-chmp-opinion-for-the-treatment-of-adults-with-resectable-mibc
Title (supplied): Astellas: PADCEV plus Keytruda CHMP positive opinion for resectable MIBC
Source date (retained): 2026-09-18
Data date (retained): 2026-09-18
Checked at: 2026-10-07T18:42:41+08:00
Timezone: Asia/Taipei
Checked-at meaning: current review of returned public web-tool extraction; not the historical network-fetch timestamp.
Retrieval mode: public_web_tool_readback_prior_ref; prior saved web_ref was opened and returned the specified original public URL.
Prior web ref: turn47view3
Current web ref: turn129view0
Read level: relevant primary-source paragraphs in web text extraction; complete original HTML/PDF bytes not saved or hashed.
Original network read time: null; not exposed by the tool. Original artifact SHA256: null.
Locator: Astellas announcement; retrieved lines 265–276, 281–282 and 291–292.
Minimum verbatim excerpts (aggregate <=25 English words):
- has adopted a positive opinion recommending the approval of PADCEV
Excerpt word count: 10
Factual extraction (values, dates, statuses; not additional prose quotations):
[
  {
    "field": "release_date",
    "original_value": "September 18, 2026",
    "unit_or_role": "calendar date",
    "locator": "L265"
  },
  {
    "field": "EU_regulatory_status",
    "original_value": "positive CHMP opinion; final EC decision expected",
    "unit_or_role": "regulatory stage as reported by company",
    "locator": "L266, L276"
  },
  {
    "field": "regimen",
    "original_value": "neoadjuvant EV + pembrolizumab, continued after radical cystectomy as adjuvant treatment",
    "unit_or_role": "treatment sequence",
    "locator": "L266"
  },
  {
    "field": "US_MIBC_scope",
    "original_value": "regardless of cisplatin eligibility",
    "unit_or_role": "company-described label scope, not substitute for C08",
    "locator": "L281"
  }
]
Support scope: Supports positive CHMP opinion for perioperative EV+pembrolizumab in resectable MIBC, distinction from final EC decision, and the Astellas/Pfizer collaboration. US status is also described as regardless of cisplatin eligibility in this company release; C08 remains the original regulatory source and was not re-read here.
Precise gap: No additional source-specific factual gap found within the assigned contribution; multi-source rows retain their other citations.
Source/data dates are supplied baseline metadata, not replaced by this check time. No alternate route, login, headers, private endpoint or payment used.
This small evidence record is an excerpt/factual extraction, not a saved full article.