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VERSION:2.0
PRODID:-//Catalyst Calendar//CN-US Event Research//ZH
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Catalyst Calendar
X-WR-CALDESC:Market-moving event research, reminders and post-event review.
BEGIN:VEVENT
UID:evt-padcev-keytruda-mibc-cisplatin-all-pdufa-aug2026@catalyst-calendar.local
DTSTAMP:20260720T200612Z
DTSTART:20260817T040000Z
DTEND:20260817T043000Z
SUMMARY:Padcev联合Keytruda围手术期MIBC适应症PDUFA窗口
DESCRIPTION:FDA将于2026年8月17日前后审评Padcev联合Keytruda用于更广泛肌层浸润性膀胱癌围手术期治疗的sBLA，可能影响尿路上皮癌早线治疗标准和ADC+IO组合估值。\\nImpact score: 70\\nExpected: FDA批准或限制Padcev+Keytruda围手术期MIBC适应症。\\nAffected: MRK(subject\, unknown\, score 78)\; PFE(subject\, mixed\, score 72)\; 4503.T(subject\, unknown\, score 68)\; ASTELLAS.PVT(licensor\, unknown\, score 62)\; CGON(peer\, mixed\, score 52)\; 688506.SH(peer\, mixed\, score 50)\\nSources: Merck Priority Review press release: https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/\\nPfizer Padcev priority review: https://www.pfizer.com/news/press-release/press-release-detail/us-fda-grants-priority-review-sbla-padcevtm-keytrudar\\nPADCEV/Keytruda Priority Review: https://www.prnewswire.com/news-releases/us-fda-grants-priority-review-to-sbla-for-padcev--keytruda-as-perioperative-treatment-for-muscle-invasive-bladder-cancer-regardless-of-cisplatin-eligibility-302746360.html\\nFDA prior approval context: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer\\nMerck Phase 3 EV-304 data: https://www.merck.com/news/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-reduced-risk-of-event-free-survival-events-by-47-and-risk-of-death-by-35-for-cisplatin-eligible-patients-with-muscle-invasive/\\nAstellas Priority Review press release: https://newsroom.astellas.com/2026-04-21-us-fda-grants-priority-review-to-sbla-for-padcev-tm-keytruda-r-as-perioperative-treatment-for-muscle-invasive-bladder-cancer-regardless-of-cisplatin-eligibility\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-padcev-keytruda-mibc-cisplatin-all-pdufa-aug2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,bladder cancer\,ADC\,immunotherapy\,Keytruda\,Padcev\,oncology
SEQUENCE:0
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TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: Padcev联合Keytruda围手术期MIBC适应症PDUFA窗口
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TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Padcev联合Keytruda围手术期MIBC适应症PDUFA窗口
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